[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Oxford University Hospitals NHS Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":216},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,38,66,90,120,145,176],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100480676","a-prospective-long-term-observational-study-in-patients-with-monoclonal-gammopathy-of-undetermined-significance-100480676",false,"NCT05539079","A Prospective Long-term Observational Study in Patients With Monoclonal Gammopathy of Undetermined Significance","SECURE","Inclusion Criteria:\n\n• Any individual with a confirmed or suspected case of MGUS\n\nExclusion Criteria:\n\n* Those who are unable or unwilling to give informed consent\n* Patients under the age of 18\n* Patients with no evidence of MGUS\n* Patients with a light chain ratio of 0.3 to 3.0 without a monoclonal protein on serum electrophoresis or immunofixation\n* Patients with rapidly rising paraprotein or serum free light chains of progressive disease at time of diagnosis or inclusion into study","ALL","18 Years",{"count":19,"type":20},2000,"ESTIMATED","OBSERVATIONAL","Multiple Myeloma (MM) is a rare blood cancer affecting over 5000 people a year in the UK. All cases of myeloma start with a condition called monoclonal gammopathy of undetermined significance (MGUS). MGUS occurs in approximately 3.2% of people aged 50 and over. Only a small proportion of these people - around 1% each year - will develop myeloma. Most people with MGUS have no symptoms, but a small number of people will suffer complications. This group are referred to as having monoclonal gammopathy of clinical significance (MGCS).\n\nPeople with myeloma frequently experience long delays in diagnosis; the delays are longer than for any other cancer. Although we know that MGUS leads to myeloma, most cases of MGUS are only found 'incidentally' when the person is having blood tests for something else. And the people who have MGUS do not have consistent testing or follow up. This situation means that 80 - 90% of people who are diagnosed with myeloma did not have an earlier MGUS diagnosis.\n\nEarlier diagnosis of myeloma might be possible with better understanding MGUS and how it should be monitored. The SECURE study will help with this. It will help confirm the rate at which people with MGUS progress to a diagnosis of myeloma. It will further understanding of screening, diagnosis, and monitoring patterns of people with MGUS and MGCS in the UK.\n\nThe study aims to find out more about the role of family history and demographic factors in the development of MGUS. It will also find out more about the psychological impact of an MGUS diagnosis and individual quality of life.\n\nPatients with MGUS will be identified by their clinical care team and invited to participate in the SECURE study. Participants will be required to answer surveys and questionnaires annually for a period of 5 years or until their disease changes. The study will recruit participants from 20 NHS sites in the UK. Some will be asked to provide blood samples. SECURE is funded by Cancer Research UK (CRUK) and the National Institute for Health Research (NIHR).",[24],"MGUS","RECRUITING","2026-08-03",{"date":28,"type":29},"2026-08-05","ACTUAL",{"date":31,"type":29},"2023-09-06",{"date":33,"type":20},"2032-12-01",{"name":35,"class":36},"Oxford University Hospitals NHS Trust","OTHER",1,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":47,"phases":48,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":63,"leadSponsor":65,"locationsCount":37},"100646044","phase-2-comparative-evaluation-of-sustained-mechanical-aspiration-thrombectomy-and-no-thrombus-modification-for-pre-stent-thrombus-burden-reduction-in-patients-with-acute-myocardial-infarction-study-the-capture-ami-study-100646044","NCT07687576","Comparative Evaluation of Sustained meChanical AsPiration Thrombectomy and no Thrombus Modification for Pre-stent Thrombus bUrden Reduction in Patients With Acute Myocardial Infarction Study: the CAPTURE AMI Study","CAPTURE AMI","Inclusion Criteria:\n\n* Primary PCI patient with ST elevation myocardial infarction\n* Angiographic criteria:\n\n  * TIMI 0\u002F1 flow at presentation\n  * Angiographic thrombus score ≥ 4\n  * Vessel diameter at site of occlusion ≥ 3.0mm (determined by coronary angiography)\n\nExclusion Criteria:\n\n* Female participant who is pregnant or lactating\n* Unconscious at presentation\n* Late STEMI presentation (symptoms onset to wire time \\> 12 h)\n* Clinically\u002Fhaemodynamically unstable patients\n* Known diagnosis of severe renal disease (CKD stage 4-5)\n* Suspected spontaneous coronary artery dissection\n* Previous CABG\n* Previous history on STEMI in the same culprit territory\n* Known moderate-severe anaemia (Hb \\\u003C 9)",{"count":46,"type":20},60,"INTERVENTIONAL",[49,50],"PHASE2","PHASE3","The CAPTURE AMI trial is an investigator-initiated, single-centre, two-arm, randomised controlled trial. Patients aged ≥ 18 years who present with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (pPCI) will be enrolled after angiographic evidence of a high thrombus burden (TIMI thrombus grade ≥ 4) and meeting the inclusion criteria laid out in section 9.2 will be 1:1 randomised to receive either standalone PCI (Arm 1) or adjunct sustained mechanical thrombectomy + PCI (Arm 2).\n\nThe CAPTURE AMI study will enrol specifically patients with:\n\nA. Evidence of high thrombus burden on coronary angiography (TIMI thrombus grade ≥ 4) B. Culprit in an artery with a diameter of 3.0 mm or more. The trial is designed to evaluate the efficacy of sustained mechanical thrombectomy versus standalone PCI in patients with a large thrombus burden assessed angiographically, with a pre-stent thrombus burden (%) as the primary imaging endpoint.",[53],"STEMI - ST Elevation Myocardial Infarction",[55,56,57,58],"Thrombus","Thrombectomy","Optical Coherence Tomography","Microvascular Injury","2026-07-08",{"date":61,"type":29},"2026-07-10",{"date":59,"type":29},{"date":64,"type":20},"2028-01-08",{"name":35,"class":36},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":37},"100570358","the-cache-study-coronary-artery-care-in-haemophilia-100570358","NCT06706206","The CACHE Study: Coronary Artery Care in HaEmophilia","CACHE","Inclusion Criteria:\n\n* Be willing and able to give informed consent for participation in the study.\n* Male, aged 45 years or above (no upper age limit).\n* Haemophilia A or B with Factor VIII\u002FIX less than 40% (0.40 IU\u002Fml).\n\nExclusion Criteria:\n\n* Participants unable or unwilling to give informed consent.\n* Participants unable to understand the English language.\n* Participants unable or unwilling to attend for the necessary scans and investigations.\n* Patients with absolute contra-indications to CT imaging will be excluded from the study. This includes:\n\n  * Any known contraindications to CT iodinated Contrast.\n  * Significant renal impairment (eGFR \\\u003C30 ml\u002Fmin).\n* Any other medical conditions which would influence the reliability of the study results determined by the investigators.","MALE","45 Years","120 Years",{"count":77,"type":20},80,"The investigators will use state-of-the-art imaging to look at heart disease in people with haemophilia. Haemophilia is an inherited disorder in which blood does not clot properly because of lack of a key 'glue' blood component (chemicals known as factor VIII or IX). People with haemophilia are 40% less likely to die of heart disease, but it is not known exactly why this is. Understanding heart disease in people with haemophilia is important because better treatments for haemophilia mean that these patients are now living longer, but doctors still don't know if the risk for heart disease in these patients as they age is the same as that for the general population. If these processes are better understand (perhaps less blood clotting is actually protecting the heart from blockage-causing clots), scientists might be able to reduce the risk of heart attacks for everybody.\n\nThe UK's first photon-counting detector cardiac CT scanner generates detailed images of the heart and its blood vessels by counting individual X-ray photons. Together with artificial intelligence tools, it is possible to extract a lot of information from these images. As people age, fat is deposited in the vessels which supply blood to the heart which forms plaques. Plaques cause narrowing of the vessels, reducing blood flow to the heart, and can also burst (rupture), leading to a blood clot and heart attack. The new CT scan will show the type and amount of plaques, and quantify the risk of plaque rupture, in people with haemophilia; and the investigators will compare this to people without haemophilia.\n\nUnderstanding the role of factor VIII\u002FIX in heart attacks will improve management of heart disease in people with haemophilia, and may also lead to new prevention and treatment strategies that benefit heart health for everyone.",[80,81],"Haemophilia","Cardiovascular Diseases","2026-03-09",{"date":84,"type":29},"2026-03-11",{"date":86,"type":29},"2025-02-25",{"date":88,"type":20},"2032-01",{"name":35,"class":36},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":47,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":37},"100566167","oxford-pleural-embolisation-trial-100566167","NCT06651658","Oxford Pleural Embolisation Trial","Pleural Blood Patch for Lung Ablation: a Randomised Trial (Oxford Pleural Embolisation Trial - OxPET)","OxPET","Inclusion Criteria:\n\n* Clinically indicated for lung ablation.\n* Willing and capable of giving informed consent.\n* Aged 18 years or above.\n\nExclusion Criteria:\n\n* Unable to proceed to lung ablation procedure.\n* 3 or more lung lesions to be ablated in the same setting.",{"count":99,"type":20},106,[101],"NA","Thermal ablation is an established treatment for lung cancer. It involves insertion of a applicator under image guidance into a lung tumour and destroying it with radiofrequency, microwave or cryotherapy. One of the common side effects is pneumothorax, which is a leak of gas from the lungs when it punctured. Air leak necessitates placement of a drainage tube in more than half of patients undergoing the procedure. The drain can be associated with some morbidity including pain, reduced mobility, prolonged hospital stay and infection Pleural embolization refers to the injection of substances to the linings of the lung to seal air leakage. There is published evidence in using pleural embolization with autologous blood (blood drawn up from the patient's veins) to prevent pneumothorax in patients undergoing lung biopsies. This technique is also known as pleural blood patch (PBP). A study involving more than 4000 patients found that PBP reduced the rates of pneumothorax by 35% and drain placement by 55% in lung patients. A study using prophylactic gelfoam torpedo embolization for radiofrequency ablation showed significant reduction in chest drain rates.\n\nIn this study, investigators plan to evaluate the PBP using a tandem needle technique in patients undergoing lung ablation at the Oxford Thermal Ablation Service, one of the largest units in the country performing about 200 ablations per year, mostly microwave ablations. Patients will be randomized to receive lung ablation with or without the PBP.\n\nThe PBP technique is easy to learn, enjoys high technical success rates and does not expose the patient to any significant additional risk.\n\nThe primary outcome is the chest drains rates in the two trial groups:\n\n1. patients undergoing lung ablation without PBP and\n2. patients undergoing lung ablation with PBP. Other outcomes that would be measured include the volume of gas leakage on Computed Tomography (CT) imaging, safety profile, length of stay, feasibility of same day discharge, patient oriented outcomes including validated pain score, and institution oriented outcomes including medical costs.\n\nA positive trial could significantly reduce the side effect profile of lung ablation and hasten the patient's recovery. There could be significant savings in healthcare costs as the procedure may become safe to perform as a day procedure as opposed to an overnight procedure.",[104,105],"Lung Cancer","Lung Metastases",[107,108,109,110,111],"lung cancer","lung metastases","lung ablation","pleural embolisation","Pleural blood patch","2026-02-02",{"date":114,"type":29},"2026-02-04",{"date":116,"type":29},"2024-11-24",{"date":118,"type":20},"2027-09",{"name":35,"class":36},{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":47,"phases":130,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":37},"100447863","hifu-ablation-of-soft-tissue-sarcoma-100447863","NCT05111964","HIFU Ablation of Soft Tissue Sarcoma","A Pilot Study in High Intensity Focused Ultrasound Ablation of Soft Tissue Sarcoma and Small Symptomatic Desmoid Tumours","SarcAblate","Inclusion Criteria:\n\n\\--------\n\nThe participant is eligible for the study if they are:\n\nWilling and able to give informed consent for participation in the study.\n\nAged 18 years or above.\n\nDiagnosed with histologically-confirmed and HIFU-targetable soft tissue sarcoma of several subtypes, including but not necessarily limited to:\n\n* Malignant fibrous histiocytoma\n* Undifferentiated (pleomorphic) sarcoma\n* Fibrosarcoma and fibromyxoid sarcoma (fibroblastic sarcomas)\n* Leiomyosarcoma\n* Liposarcoma\n* Malignant peripheral nerve sheath tumour\n* Retroperitoneal sarcoma\n* Rhabdomyosarcoma\n* Synovial sarcoma\n* Sacral chordoma (following amendment)\n* Desmoid tumours (intra- or extra-abdominal, following amendment)\n\nHave at least one of the following:\n\n* Untreated or recurrent primary resectable STS tumour 1-5cm diameter, targetable by HIFU\n* Infield recurrent primary resectable STS tumour of \\>1cm diameter, targetable by HIFU\n* Primary or metastatic STS unsuitable for resection or further chemo- or radiotherapy, targetable by HIFU\n* Small (1-8cm) symptomatic intra- or extra-abdominal desmoid tumour, targetable by HIFU, which is not indicated for surgery (or patient has declined surgery)\n\nHave life expectancy of over 12 months and a World Health Organisation (WHO) performance status of less than or equal to 1.\n\nBe able to attend Churchill Hospital and Nuffield Orthopaedic Center, Oxford, potentially for multiple visits, and thus be based in the UK.\n\nWilling to allow his or her GP and Consultant to be notified of participation in the study.\n\nAble and willing to give written informed consent, indicating that they are aware of the investigational nature of this study and potential risks, and able to comply with the protocol for the duration of the study, including scheduled follow-up visits and examinations.\n\nExclusion Criteria:\n\n\\--------\n\nThe participant may not enter the study if ANY of the following apply:\n\nDiagnosed with histologically confirmed Osteosarcoma or Chordoma\n\nDiagnosed with histologically confirmed soft tissue sarcoma of the following subtypes:\n\n* GIST\n* Chondrosarcoma\n* Kaposi's sarcoma\n* Ewings sarcoma\n* Giant cell tumour\n* Angiosarcoma\n\nActive medical or psychological illness that would render the patient unsuitable for the interventions required for the study (exclusion at the discretion of the investigator).\n\nPregnancy.\n\nUlceration \u002F skin breakdown \u002F erythema overlying the target tumour site due to tumour invasion (exclusion at the discretion of the investigator).\n\nSignificant radiation skin damage overlying the target tumour site (exclusion at the discretion of the investigator).\n\nImpractical anatomical locations for HIFU targeting (using JC200 treatment device) (exclusion at the discretion of the investigator):\n\n* Retroperitoneum\n* Skull\n* Neck\n* Axilla\n* Foot\n\nUnfavourable imaging features on previously acquired cross-sectional imaging, including:\n\n* Tumour within 1cm of the skin surface\n* Interposition (or close proximity) of a gas-containing structure between tumour and skin such as fixed (retroperitoneal) bowel or lung\n* Interposition of a continuous ossified bone between tumour and skin, such as coverage by pelvis or scapula\n* Tumour margin close (\\\u003C1.5cm) or encasing major neurovascular bundles (such as the sciatic nerve)\n* Tumour margin close (\\\u003C1.5 cm) to critical visceral structures (e.g. bladder or bowel)\n\nRecent radiotherapy (under 6 months) to the target tumour site.\n\nRecent surgery (under 6 weeks) to the target tumour site.\n\nHave any known allergic reactions to intravenous imaging agents to be used in this study (exclusion at the discretion of the investigator).\n\nHave contraindication(s) or intolerance to MRI (exclusion at the discretion of the investigator).\n\nCurrent involvement in phase 1 studies.\n\nSoft tissue sarcoma participants: Use of chemotherapy or of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the intervention.\n\nDesmoid participants: hormonal medication including the contraceptive pill or tamoxifen, or being treated with imatinib.",{"count":129,"type":20},10,[101],"Around 3,300 people are diagnosed with soft tissue sarcoma (STS) each year in the UK, and a significant proportion of STS diagnoses are in people aged under 30 years. STS can arise from various tissue types and is comprised of over 50 tumour types. Although STS is treated with a combination of surgery, radiotherapy and chemotherapy, the prognosis is relatively poor with a five-year survival rate of 54%. There is an unmet need for further treatment modalities in STS.\n\nHigh intensity focused ultrasound (HIFU) is a non-invasive way of treating cancers with minimal side effects, low complication rate and quick recovery. Ultrasound waves are used to destroy tumour cells and improvements in technology and experience are enabling complete destruction of tumour. HIFU also releases tumour antigens, increasing the immune response against cancer. HIFU has received FDA approvals for several indications, including bone metastases and we are using a CE-approved HIFU device in Oxford (UKCA-approvals anticipated for 2023). There have been some publications from China showing promise in STS, however this technology needs further evaluation within the UK's healthcare setting.\n\nThis study will recruit patients with both resectable and unresectable STS, in addition to unresectable small symptomatic desmoid tumours. 12-16 patients, and a minimum of 10 patients with malignant STS, will be treated over a maximum recruitment period of three years. HIFU treatment will be carried out as a day case procedure, and patients will be expected to be discharged home the same day.\n\nThe study is designed to generate evidence regarding safety and feasibility of HIFU for ablation of STS and intra-abdominal desmoids. In addition, the study is anticipated to provide information about the efficacy of HIFU against these tumour types which can help in the design of later phase studies. Short-term outcomes include feasibility, safety and the completeness of destruction of the tumour. Long-term outcomes include one-year survival, local recurrence and quality of life metrics (including pain scores). The study will also look at immunological response following ablation of STS using both blood and tumour samples pre- and post-HIFU ablation.",[133,134],"Soft Tissue Sarcoma","Desmoid Tumors",[136,137,138],"HIFU","Focused Ultrasound","Immunology",{"date":114,"type":29},{"date":141,"type":29},"2021-12-10",{"date":143,"type":20},"2027-12-10",{"name":35,"class":36},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":153,"sex":154,"minAge":155,"maxAge":156,"enrollmentInfo":157,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":37},"100336573","investigating-the-structured-use-of-ultrasound-scanning-for-fetal-growth-100336573","NCT03662178","Investigating the Structured Use of Ultrasound Scanning for Fetal Growth","Investigating the Structured Use of Ultrasound Scanning for Fetal Growth (Oxford Growth Restriction Identification Programme (OxGRIP)) on Risk Factors for and the Incidences of Adverse Maternal, Fetal and Neonatal Outcome","OxGRIP","Inclusion Criteria:\n\n• All pregnant women receiving antenatal care at the Oxford University Hospitals NHS Foundation Trust (OUHFT) from January 2013 to 31st December 2019 with no exclusion criteria\n\nExclusion Criteria:\n\n* Women who have opted out of research related to pregnancy in this pregnancy whilst receiving care by the OUHFT.\n* If intrapartum care takes place outside of the OUHFT.",true,"FEMALE","16 Years","60 Years",{"count":158,"type":20},56000,"Fetal growth restriction during pregnancy represents one of the biggest risk factors for stillbirth (Gardosi et al, 2013), with 'about one in three term, normally formed antepartum stillbirths are related to abnormalities of fetal growth' (MBRRACE, 2015).\n\nTherefore, antenatal detection of growth restricted babies is vital in order to be able to monitor and decide the appropriate delivery timing.\n\nHowever, antenatal detection of SGA babies has been poor, varying greatly across trusts in England in those that calculate their rates (NHS England, 2016). Most trusts do not calculate their detection rates and rates are therefore unknown. It is estimated that routine NHS care detects only 1 in 4 growth restricted babies (Smith, 2015).\n\nOxford University Hospitals NHS Foundation Trust, in partnership with the Oxford Academic Health Science Network (AHSN) has introduced a clinical care pathway (the Oxford Growth Restriction Pathway (OxGRIP)) designed to increase the rates of detection of these at risk babies. The pathway is intended to increase the identification of babies who are at risk of stillbirth, in order to try to prevent this outcome, whilst making best usage of resources, and restricting inequitable practice and unnecessary obstetric intervention.\n\nIt has been developed with reference to a body of research, however, the individual parts of care provided have not been put together in a pathway in this manner before. Therefore it is important to examine whether the pathway meets its goals of improving outcomes for babies in a 'real world' setting.\n\nThe principles of the pathway are\n\n1. A universal routine scan at 36 weeks gestation.\n2. Additional growth scans at 28 and 32 weeks gestation based on a simplified assessment of risk factors and universal uterine artery Doppler at 20 weeks gestation.\n3. Assessment of further parameters other than estimated fetal weight associated with adverse perinatal outcome (eg growth velocity, umbilical artery Doppler and CPR).\n\nThe clinical data routinely collected as a result of the introduction of the pathway offers a valuable and unique resource in identifying and analysing in the effects of the pathway on its intended outcomes and also in investigating and analysing other maternal, fetal and neonatal complications and outcomes, establishing normal \u002F reference ranges for ultrasound values.",[161,162,163,164,165,166,167],"Stillbirth","Fetal Death","Fetal Growth Retardation","Small for Gestational Age","Fetal Growth Restriction","Perinatal Death","Intrauterine Growth Restriction","2026-01-27",{"date":170,"type":29},"2026-01-29",{"date":172,"type":29},"2017-09-01",{"date":174,"type":20},"2029-09-30",{"name":35,"class":36},{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":47,"phases":186,"briefSummary":188,"conditions":189,"keywords":194,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":37},"100616282","phase-4-individualised-cryoneurolysis-to-treat-pain-in-the-context-of-spasticity-in-the-upper-and-lower-extremities-100616282","NCT07303582","Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities","Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities (ICE): a Pilot Randomised Controlled Trial","ICE","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the trial OR a positive opinion from a consultee is provided by a family member or carer (relative or friend) willing to provide personal consultee (PC) advice.\n* Male or Female, aged 18 years or above.\n* Diagnosed with a central neurological condition, including acquired brain injury (e.g. from ischaemic stroke, trauma, or haemorrhage), multiple sclerosis, and spinal cord injury.\n* Clinical indication for Botulinum Toxin and Cryoneurolysis treatment, including pain associated with spasticity and with a clinically meaningful response to diagnostic nerve block to specific nerves or nerve branches that can be treated with cryoneurolysis.\n* At least one rehabilitation goal related to management of pain resulting from spasticity.\n\nExclusion Criteria:\n\n* Participant has received Botulinum toxin or cryoneurolysis within the last 90 days.\n* Raynaud's syndrome.\n* Cryoglobulinaemia.\n* Cold urticaria.\n* Bleeding disorders.\n* Localised infection at intended treatment site.\n* Planned oral antispasmodic medication dose changes.\n* Pregnancy, breastfeeding, or planning pregnancy in the trial period.\n* Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.\n* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.\n* Participants who are currently enrolled in another trial may be excluded if it is deemed (in the investigator's opinion) that participation could influence the results for either study.",{"count":185,"type":20},50,[187],"PHASE4","Spasticity is an umbrella term for impairments of muscle tone and control in people with damage to the brain and spinal cord. It is highly prevalent and results in pain, stiffness, and contribute to difficulties in activities of daily living. Current treatment options are limited, and many people experience only partial reduction in spasticity and frequent repeated treatments are needed.\n\nCryoneurolysis is a medical technique which involves the controlled freezing of the nerves. It has been approved in the UK for the treatment of pain in the context of spasticity through the targeting of nerves which control problematic muscles. Oxford University Hospitals NHS Foundation Trust has been offering this treatment routinely since January 2024. This pilot study aims to improve the understanding of the potential effectiveness of this treatment and its potential side effects when compared with a more commonly used treatment (Botulinum Toxin).\n\nParticipants will be randomly allocated to receive usual care with Botulinum Toxin (control group) or usual care with Cryoneurolysis (intervention group). The investigators will assess pain, goal attainment, side effects, spasticity, disability and independence in daily activities, and movement of the arm and leg. Assessments will be at baseline and then 6-, 12-, 18-, and 24-weeks following treatment. Participants who are randomised to the control group will have the opportunity to receive cryoneurolysis treatment after the 12 week follow up assessment.\n\nThe results of this study will help to guide future studies to examine the effectiveness of this treatment.",[190,191,192,193],"Centreal Neurological Condition","Acquired Brain Injury (Including Stroke)","Multiple Sclerosis","Spinal Cord Injury",[195,196,197,198,199,192,193,200,201,202,203,204,205,206,207],"Cryoneurolysis","Spasticity","Pain","Acquired Brain Injury","Stroke","Central Neurological Condition","Botulinum Toxin (botox)","Iovera","Chemodenervation","BoNT-A","Cryoneurotomy","Cryoneurectomy","Cryoanalgesia","2025-12-10",{"date":210,"type":29},"2025-12-26",{"date":212,"type":29},"2025-12-02",{"date":214,"type":20},"2026-11-30",{"name":35,"class":36},""]