Phase 2a Study of Polyethylene Glycol PEG Fusion Compared to Standard Nerve Repair for Acute Upper Extremity Peripheral Nerve Injuries

What this Trial Is About

Researchers are investigating the safety and effects of polyethylene glycol PEG fusion in patients with acute upper extremity peripheral nerve injuries. This Phase 2a randomized controlled trial aims to compare PEG fusion combined with primary nerve repair or reconstruction to conventional nerve reconstruction. The study seeks to establish safety data and assess clinical outcomes such as recovery of sensory and motor function, range of motion, hand strength, disability, pain, and patient satisfaction over up to two years. The trial will enroll 40 patients who have sustained complete peripheral nerve injuries in the upper extremity within 48 hours. Participants will be randomly assigned to receive either PEG-mediated nerve reconstruction using NTX-001 applied topically via a surgical device or conventional nerve reconstruction without PEG. NTX-001 is used as an adjunct during nerve repair surgery to promote axonal membrane fusion. The study hypothesizes that PEG fusion will have comparable short-term complication rates and may lead to earlier and improved functional recovery compared to standard surgery. Participants will be monitored for complications within the first 30 days and followed for up to two years to evaluate nerve regeneration and functional outcomes. Assessments include sensory and motor function recovery, range of motion, hand strength, pain levels, disability, and treatment satisfaction. The trial involves regular clinical evaluations to track progress and safety, with data also compared to an external prospective study for validation. Total participation duration spans up to two years post-surgery.

Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)