[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neuraptive Therapeutics Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":63},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":18,"enrollmentInfo":4,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":62,"locationsCount":5},"100482731","ntx-001-to-repair-peripheral-nerve-transections-100482731","NCT05565846","NTX-001 to Repair Peripheral Nerve Transection(s)","An Open-Label Study Using NTX-001 to Repair Peripheral Nerve Transection(s)","Inclusion:\n\n1\\. The patient has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and\u002For sensory impairment and requires surgical treatment.\n\nExclusion:\n\n1. Patients whose nerve repair will occur greater than 48 hours after nerve transection.\n2. Patients requiring repair of the intracranial portion of any nerve.\n3. Patients requiring a nerve repair involving an allograft or conduit.\n4. Patients expected to show signs of spontaneous recovery by 12 months (e.g., Bell's palsy).\n5. Patients 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.\n6. The patient 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).\n7. The patient has a known allergy to polyethylene glycol (PEG) or human grade silicone.","12 Years","EXPANDED_ACCESS","The proposed use of NTX-001 for transections of upper extremity and facial peripheral nerves, acutely or planned.",[57],"Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial Nerves","AVAILABLE","2026-06-26",{"date":61,"type":37},"2026-06-30",{"name":43,"class":44},""]