[{"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":45},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":19,"type":20},98,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27],"Peripheral Nerve Injury Upper Limb","Peripheral Nerve Injury (PNI)",[29,30,31],"Transected Nerves","Requiring Surgical Repair","Upper Extremity","RECRUITING","2026-06-29",{"date":35,"type":36},"2026-07-01","ACTUAL",{"date":38,"type":36},"2025-02-10",{"date":40,"type":20},"2027-04-30",{"name":42,"class":43},"Neuraptive Therapeutics Inc.","INDUSTRY",24,""]