[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624231":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":40,"armGroups":47,"interventions":54,"overallOfficials":40,"centralContacts":60,"locations":66,"responsibleParty":91,"collaborators":94,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":40,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":40,"enrollmentInfo":107,"targetDuration":40,"studyType":110,"phases":111,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":69,"whyStopped":40,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":40},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"Technical Success Rate","This involves assessing the procedural success of the POEM using the novel bipolar device. Success would typically mean completing the procedure as planned, without technical difficulties or complications.\n\nUnit of measure: % of procedures","1 day",{"measure":14,"description":15,"timeFrame":16},"Clinical Success Rate","Clinical success rate is defined as the proportion of patients in whom clinical success (as defined by an Eckardt symptom score ≤ 3) is achieved following the procedure.\n\nThe Eckardt score (range 0-12) will be assessed for each patient before the procedure and at the 1 month postoperative follow-up. Clinical success for an individual patient is defined as achieving a follow-up Eckardt score of 3 or less. The clinical success rate is the percentage of patients who meet this success criterion out of the total analyzed population.\n\nUnit of measure: % of patients","30 days",{"measure":18,"description":19,"timeFrame":12},"[Safety] Incidence of intraoperative complications","Incidence of adverse events occurring during the procedure, including: perforation, bleeding, infection, and any complications directly related to the device.\n\nUnit of measure: % of procedures",{"measure":21,"description":22,"timeFrame":16},"[Safety] Incidence of postoperative complications","Incidence of adverse events occurring within 30 days after the procedure, including: perforation, bleeding, infection, and any complications directly related to the device.\n\nUnit of measure: % of procedures",[24,27,31,34,37],{"measure":25,"description":26,"timeFrame":16},"Post-Procedural Reflux - Symptom Assessment","Reflux symptoms reported by the patient after the POEM procedure. Patient-reported symptoms tracked during follow-up visits.\n\nUnit of Measure: Presence\u002Fabsence and description of symptoms (Categorical).",{"measure":28,"description":29,"timeFrame":30},"Post-Procedural Reflux - Endoscopic Features","The presence of esophagitis features identified during endoscopic examination. Endoscopic examination performed at postoperative 6 months follow-up.\n\nUnit of Measure: Presence\u002Fabsence and grading of esophagitis (Categorical).","6 months",{"measure":32,"description":33,"timeFrame":16},"Post-Procedural Reflux - pH Monitoring","Quantitative assessment of acid reflux. A pH level below 4 for more than 6% of the monitoring period is considered indicative of significant reflux. Measured by the number of patients with significant reflux at postoperative 1 month follow-up divided by total number of patients.\n\nUnit of measure: % of patients",{"measure":35,"description":36,"timeFrame":30},"Distensibility of the Lower Esophageal Sphincter (LES)","The distensibility of the LES, an important parameter in Achalasia treatment, will be measured using the EndoFLIP® system during the 6-month follow-up endoscopic examination. It is measured as the Distensibility Index (DI).\n\nUnit of Measure: mm²\u002FmmHg for DI.",{"measure":38,"description":39,"timeFrame":30},"Postoperative Northwestern Esophageal Quality of Life questionnaire (NEQOL) score","The NEQOL questionnaire, a tool designed to measure the quality of life specifically in patients with esophageal conditions, will be administered 6 months post-procedure. The NEQOL questionnaire is consisted of 14 questions answered on a 5-point Likert scale, where higher score means a better health-related quality of life (HRQOL).\n\nUnit of Measure: score (0-56)",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"NA","SINGLE_GROUP","TREATMENT",{"masking":46,"maskingDescription":40,"whoMasked":40},"NONE",[48],{"label":49,"type":50,"description":51,"interventionNames":52},"SpydrBlade Flex Group","EXPERIMENTAL","Patients will undergo Per-Oral Endoscopic Myotomy (POEM) using the novel SpydrBlade Flex device.",[53],"Device: SpydrBlade Flex",[55],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":40},"DEVICE","SpydrBlade Flex","The POEM procedure will be performed using the novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK). Both anterior and posterior POEM could be performed, depending on the clinical presentation and endoscopist's preference.",[49],[61],{"name":62,"role":63,"phone":64,"phoneExt":40,"email":65},"Hon Chi Yip","CONTACT","+852 3505 2956","hcyip@surgery.cuhk.edu.hk",[67,79],{"facility":68,"status":69,"city":70,"state":40,"zip":40,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":40},"academy tertiary, IECED","RECRUITING","Guayaquil","Ecuador","EC",{"type":74,"coordinates":75},"Point",[76,77],-79.88621,-2.19616,{"lat":77,"lon":76},{"facility":80,"status":69,"city":81,"state":40,"zip":40,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong","Hong Kong","HK",{"type":74,"coordinates":84},[85,86],114.17469,22.27832,{"lat":86,"lon":85},[89],{"name":62,"role":63,"phone":90,"phoneExt":40,"email":65},"+85235052956",{"type":92,"investigatorFullName":62,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Assistant Professor",[95],{"name":96,"class":97},"Academy tertiary center, IECED, Guayaquil, Ecuador","UNKNOWN","100624231","safety-and-efficacy-of-a-novel-spydrblade-flexible-bipolar-in-poem-100624231",false,"NCT07406945","Safety and Efficacy of a Novel SpydrBlade Flexible Bipolar in POEM","Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Per-Oral Endoscopic Myotomy in Patients With Achalasia: A Multicenter Prospective Study","Inclusion Criteria:\n\n* Patients with 18 years of age or older.\n* Patients referred to the participating center with a clinical indication for POEM. This includes conditions such as: achalasia, native or failed Heller myotomy, balloon dilation, and EGJ outflow obstruction.\n* Patients who provide informed consent.\n\nExclusion Criteria:\n\n* Patients who have contraindications for EGD.\n* Patients with an Eckardt score \\\u003C 3 before POEM.\n* Positive diagnosis of Chagas disease.\n* Patients unable to withstand general anesthesia.","ALL","18 Years",{"count":108,"type":109},73,"ESTIMATED","INTERVENTIONAL",[42],"Achalasia is an idiopathic motility disorder, primarily identified by the absence of esophageal peristalsis and the inability of the lower esophageal sphincter (LES) to relax properly. Although it is usually misdiagnosed and treated as gastroesophageal reflux disease (GERD), the main symptom is progressive dysphagia, accompanied by additional symptoms like nocturnal cough, heartburn, weight loss, regurgitation of undigested food and aspiration.\n\nThe severity of achalasia and the effectiveness of treatments are commonly assessed using the Eckardt Symptom Score (ESS), which evaluates symptoms like weight loss, regurgitation, dysphagia, and retrosternal pain.\n\nDiagnosis of achalasia is often delayed, affecting up to 50% of patients. It typically involves a combination of diagnostic tools, such as time barium esophagram (TBE) study, which assesses the movement and clearance of barium in the esophagus; esophagogastroduodenoscopy (EGD), which allows visual examination of the esophagus, stomach, and duodenum; and high-resolution esophageal manometry (HREM), considered the gold standard for achalasia. HREM can also help stratify the condition into different types, influencing treatment choices. Furthermore, the endoluminal functional lumen imaging probe (Endoflip, Crospon Corp, Dangan Galaway, Ireland), which measures baseline parameters of LES, aiding in both diagnosis and treatment evolution.\n\nWhile there is no cure for achalasia, treatments aim to reduce LES pressure. The include pharmacological treatments, such as calcium channel blockers or nitrates; endoscopic treatment, including injection of botulinum toxin in the LES, pneumatic dilation, or per-oral endoscopic myotomy (POEM); and surgical therapies (laparoscopic Heller myotomy). POEM has emerged as a first-line treatment for achalasia due to its minimally invasive nature and high success rates (80%-90%). This technique involves creating a submucosal tunnel and performing myotomy, and it can be performed anteriorly (at 2 o'clock) or posteriorly (at 5 o'clock).\n\nThe choice between anterior and posterior approaches to POEM often depends on the endoscopist's experience and preference. While current data is inconclusive regarding the superiority of either approach, some suggest that the posterior approach might be technically easier due to procedural characteristics (i.e., alignment between endoscopic accessories and mucosal incision). The introduction to novel technologies with smaller diameters can improve this minimally invasive approach making the procedure more efficient and safer for patients with achalasia. Thus, we aim to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for per-oral endoscopic myotomy in patients with achalasia.",[114,115],"Achalasia","EGJ Outflow Obstruction",[117,118],"Novel Flexible Bipolar","POEM","2026-02-06",{"date":121,"type":122},"2026-02-12","ACTUAL",{"date":124,"type":122},"2024-11-01",{"date":126,"type":109},"2027-04-01",{"name":5,"class":6},2]