Phase 2a, Multicenter, Randomized, Patient and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to SOC in the Treatment of Acute Single Transected Peripheral Nerve Injury Occurring Below the Distal Border of the Brachial Plexus Requiring Surgical Repair.

NTx20201

NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 16 and 80 years of age.

2020-09-25

2023-08-15

2024-08-15

Active (not recruiting)

Early phase I

51

Inclusion Criteria: * The subject is at least 12 years of age and not older than 80. * The subject has sustained a confirmed (intra-op assessment) single transected peripheral nerve injury. * The subject's nerve injury is classified as Sunderland's Fourth and Fifth Degree (Class III) * The subject's nerve injury is amenable to minimal or acceptable tension, in direct, end-to-end repair. * The surgical repair will occur within 48 hours of injury. Exclusion Criteria: * The subject has a PNI with a segmental loss (gap) that cannot be repaired with minimal or acceptable tension. * Other treatments known to affect the growth and/or physiology of the neural and vascular system. * The nerve injury has vascular damage that cannot be repaired to provide adequate perfusion of the injured site. * The subject is pregnant and/or is breastfeeding. * The subject has a significant medical comorbidity precluding immediate repair.

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2024-02-06