[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peripheral-nerve-injury-pni\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peripheral-nerve-injury-pni":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100563427","phase-3-this-study-will-evaluate-the-effectiveness-of-ntx-001-a-surgical-nerve-repair-product-when-used-in-people-with-upper-extremity-nerve-lacerations-100563427",false,"NCT06616025","This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.","Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care (Neurorrhaphy) in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair.","Inclusion Criteria:\n\n* The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form.\n* The subject is between eighteen (18) and eighty (80) years of age.\n* The subject has clinical evidence of a Sunderland's 4th degree (Class II) or 5th degree (Class III) nerve transection(s) that has resulted in upper extremity nerve impairment that requires surgical treatment.\n\nExclusion Criteria:\n\n* Subjects whose nerve repair will occur greater than 48 hours after nerve transection.\n* Subjects requiring nerve repair involving an autograft, allograft or conduit(s).\n* Subjects with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair.\n* Subjects who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow up due to significant muscle atrophy or other morbidity.\n* The subject's injury is a result of a suicide attempt or self- harm.\n* The subject has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and\u002For physiology of the neural and vascular system).\n* The subject has a known allergy to polyethylene glycol (PEG) or human grade silicone.\n* The subject is pregnant or breastfeeding.\n* The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.","ALL","18 Years","80 Years",{"count":20,"type":21},98,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.",[27,28],"Peripheral Nerve Injury Upper Limb","Peripheral Nerve Injury (PNI)",[30,31,32],"Transected Nerves","Requiring Surgical Repair","Upper Extremity","RECRUITING","2026-06-29",{"date":36,"type":37},"2026-07-01","ACTUAL",{"date":39,"type":37},"2025-02-10",{"date":41,"type":21},"2027-04-30",{"name":43,"class":44},"Neuraptive Therapeutics Inc.","INDUSTRY",24]