[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"digital-nerve-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:digital-nerve-injury":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,41,72,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100651039","secure-post-market-study-100651039",false,"NCT07756489","SECURE Post-Market Study","SECURE Post-Market Study (PMS): Atraumatic Sutureless Nerve Repair - Evaluation of COAPTIUM CONNECT in a REal-World Clinical Setting","SECURE PMS","Inclusion Criteria:\n\n1. Subjects aged 18 years or older at the time of signing the informed consent form.\n2. Subjects undergoing surgical repair of an acute peripheral nerve injury as follows:\n\n   1. Digital sensory nerve with associated tendon injury, OR\n   2. Digital sensory nerve without tendon injury.\n3. Nerve must be completely transected and appropriate for primary repair.\n4. Nerve ends can be reapproximated without excessive tension and without the need for nerve grafting.\n5. Wound can be adequately cleaned and has sufficient healthy soft tissue to allow primary closure without adjunctive soft tissue procedures.\n6. Nerve injury is deemed by the surgeon to be suitable for repair using COAPTIUM® CONNECT.\n7. Subject is willing and able to provide written informed consent prior to any study specific procedures.\n8. Subject is willing and able to complete all required visits and procedures at baseline, 1 month, 3 months, 6 months, and 12 months.\n\nExclusion Criteria:\n\n1. Known or suspected hypersensitivity to any constituents of the product, including the polymer (Aminated polyglycerol sebacate acrylate) or the additive FD\\&C Blue No. 1 Dye (brilliant blue FCF);\n2. Known diagnosis of peripheral neuropathy;\n3. Any injury requiring revascularization due to critical ischemia from damage to the blood vessels;\n4. Subject's traumatic lesion is older than 14 days at the time of surgery;\n5. Use of photosensitizing medications at the time of informed consent.\n6. Concomitant neuromodulator medication;\n7. Life expectancy less than 1 year;\n8. History of neuropathic pain in the affected extremity;\n9. History of injury to the nerve being studied;\n10. Missing contralateral digit or history of injury to the contralateral digit (comparison\u002Fcontrol area);\n11. Unwillingness\u002Finability to follow postoperative instructions\u002Ffollow-up visits;\n12. Concomitant intake of systemic immunosuppressive medications, steroids (\\>20mg of prednisone \u002Fday or equivalent) and chemotherapy;\n13. Prior radiation therapy to the surgical site;\n14. Pregnancy detected by a positive pregnancy test or planned pregnancy during the study period or breast-feeding women;\n15. History of chronic ischemic disease involving the affected limb;\n16. Diagnosis of type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus (at the discretion of the investigator);\n17. Subject is currently participating in a study involving an investigational device\u002Fdrug that has not reached its primary endpoints or would interfere with the study endpoints.\n\n    Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials;\n18. Previous injury, surgery, pathology involving the same nerve or extremity;\n19. Active infection at the surgical site;\n20. In the opinion of the Investigator, the subject is not a suitable candidate for the clinical investigation.","ALL","18 Years",{"count":20,"type":21},65,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this post-market study is to generate post-market, real- world evidence on the safety and performance of COAPTIUM® CONNECT with TISSIUM® LIGHT for the atraumatic sutureless repair of acute digital (sensory) injuries of the hand in adults through prospective data collection, to confirm safety and performance of the device.",[27,28],"Acute Peripheral Nerve Injuries","Digital Nerve Injury","NOT_YET_RECRUITING","2026-08-04",{"date":32,"type":33},"2026-08-10","ACTUAL",{"date":35,"type":21},"2026-10",{"date":37,"type":21},"2028-10",{"name":39,"class":40},"Tissium","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100633267","phase-4-mochida-refeel-for-digital-nerve-injuries-100633267","NCT07524465","Mochida ReFeel for Digital Nerve Injuries","Investigator-led Observational Clinical Research Project Evaluating the Impact of the ReFeel for Digital Nerve Injuries.","Inclusion Criteria:\n\n* Age 18-69 years\n* Digital nerve injury in at least one digit requiring repair with a gap of 1-25mm\n* Able to provide tension free end to end nerve coaptation\n* Have uninjured contralateral or adjacent digit that is suitable to serve as a referenced digit for baseline functional assessments.\n* Willing to comply with follow up for visits up to 12 months.\n\nExclusion Criteria:\n\n* Estimated distance of recovery greater than 150 mm (from proximal site of to the tip of the digit)\n* Injury distal to distal interphalangeal joint\n* Extensive soft tissue injury that will impair recovery assessment\n* Incomplete nerve transections\n* Injury requiring replantation of the target digit\n* Injuries to the affected nerve proximal to the superficial arch\n* Nerve injuries \\> 24 weeks after initial injury\n* End to side nerve repair\n* Injuries with vascular damage resulting in inadequate perfusion despite repair\n* Subjects with type 1 diabetes or type 2 diabetes requiring regular insulin therapy\n* Subjects who are undergoing or expected to undergo treatment with chemotherapy, radiation therapy, or other know treatment that affects the growth of neural and\u002For vascular system\n* History of neuropathy, diabetic neuropathy, or another known neuropathy\n* Excepted use of medication during the study that is known to impact nerve regeneration or cause peripheral neuropathy such as immunosuppressant's and Chemotherapeutic\n* History of chronic ischemic condition of the upper extremity.\n* Workers Compensation","69 Years",{"count":50,"type":21},5,[52],"PHASE4","This is an Investigator Led single-center, Prospective and Observational, Clinical Research Project. The specific aim of this study is to test\u002Fobserve the safety and effectiveness of the ReFeel Device for Digital nerve injury in improving recovery time and outcomes. The primary objective of this study is to monitor clinical and surgical procedural outcomes for the use of ReFeel device.",[28,55],"Nerve Reconstruction",[57,58,59,60,55],"ReFeel","Digital Nerve","Nerve Gap","Mochida","2026-04-08",{"date":63,"type":33},"2026-04-13",{"date":65,"type":21},"2026-05-01",{"date":67,"type":21},"2028-12-31",{"name":69,"class":70},"OrthoCarolina Research Institute, Inc.","OTHER",1,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":50},"100582736","evaluating-therapeutic-electrical-stimulation-to-improve-nerve-healing-after-surgical-repair-of-digital-nerve-injuries-100582736","NCT06867185","Evaluating Therapeutic Electrical Stimulation to Improve Nerve Healing After Surgical Repair of Digital Nerve Injuries","Function And Speed of Transection Recovery After Therapeutic Electrostimulation of Nerves","FASTR-TEN","Inclusion Criteria:\n\n* Age 18-80 years\n* Candidate for surgical intervention under general anesthesia.\n* Require primary nerve injury repair in at least 1 digital nerve.\n* Following resection, have a resulting nerve gap of ≤ 10mm.\n* Able to complete tension-free end-to-end direct repair, or repair with a conduit, autograft, or allograft with a length ≤15mm\n* Signed and dated informed consent form.\n\nExclusion Criteria:\n\n* Severe comorbid conditions, such as arrhythmia or congestive heart failure, preventing surgery under general anesthesia.\n* Nerve repair occurring \\>1 month post-injury.\n* Incomplete nerve transection.\n* Injury requiring replantation of target digit\n* Injury distal to the distal interphalangeal joint.\n* Injury proximal to branching into the proper or common digital nerves.\n* Injuries to both digital arteries of an affected digit.\n* History of neuropathy, diabetic neuropathy, or any other known neuropathy\n* History of chronic ischemic condition of the upper extremity\n* Cognitive impairment preventing the ability to provide consent, follow post-operative instructions, or complete clinical assessments.","80 Years",{"count":82,"type":21},60,[24],"The goal of this clinical study is to evaluate if a period of electrical stimulation delivered during the surgical repair procedure can speed up nerve healing.",[28,86,55,87,88],"Nerve Injury","Nerve Trauma","Digital Nerve Lesion",[90,91,92,93],"Nerve Repair","Therapeutic Electrical Stimulation","BES","Brief Electrical Stimulation","RECRUITING","2026-01-08",{"date":97,"type":33},"2026-01-09",{"date":99,"type":33},"2025-04-24",{"date":101,"type":21},"2027-03",{"name":103,"class":40},"Checkpoint Surgical Inc.",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":117,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":71},"100480486","cast-or-epineural-suture-for-digital-nerve-injuries---a-randomised-controlled-study-100480486","NCT05536609","Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study","COPS","Inclusion Criteria:\n\n* Clinical signs of isolated traumatic digital nerve injury in digits 2, 3, 4 or 5.\n* Patient age =\\> 20 years on day of injury.\n* Injury location on volar aspect of finger.\n* Acute sensory dysfunction in suspected digital nerve injury area.\n\nExclusion Criteria:\n\n* Digital nerve injury ot the thumb\n* Digital nerve injury in the palm of the hand (i e proximal to the finger base)\n* Patient does not speak or read the Swedish language.\n* Abusive drug or alcohol use\n* Dementia.\n* Injury mor than 7 days at dianosis AND\u002FOR operative treatment cannot be offered within 10 days from injury.\n* Neurologic disease.\n* Ongoing infektion in the injured finger.\n* concomittant tendoninjury or fracture in injured or adjacent finger.\n* Injury mechanism is of blunt or crush charachter","20 Years",{"count":113,"type":21},166,[24],"Nerve injury in the fingers is a common injury and affects people of all ages. The treatment usually offered to patients is surgery and various types of rehabilitation. There is a lack of knowledge and research on how these injuries should be treated in the best way and how well sensory function can be restored after an injury. In this research project, we will investigate results after treatment for digital nerve injuries by entailing a randomised controlled trial allocating patients with isolated digital nerve injuries to either surgical repair or non-operative treatment in a cast. Primary outcome is digital nerve function as measured by 2-points discrimination at 1 year after treatment. Secondary outcomes include finger mobility, dexterity, handfunction, occurence of pain and anxiety and time on sick leave.",[28],[118,119,120,121,122],"digital nerve injury","digital nerve lesion","randomised controlled study","surgical nerve repair","non-operative treatment","2025-12-05",{"date":125,"type":33},"2025-12-12",{"date":127,"type":33},"2022-08-29",{"date":129,"type":21},"2031-12-31",{"name":131,"class":70},"Karolinska Institutet"]