Nerve Repair Study: PEG-Fusion 

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

What is the study?

This study is a randomized trial  being conducted for an institutional sponsor to assess the safety of a new nerve repair method. 

Group 1: standard repair method (end-to end nerve repair without a conduit or graft)

Group 2: repair with investigational drug/device combo

Subject follow-up evaluations will occur at Baseline, at Weeks 4, 8, 12, 24, 36 and 48 following surgical repair. Patients will be blinded to their treatment group.

Are you eligible to participate in this study?

Inclusion Criteria:

  • Between the ages of 18-65
  • Less than 48 hours from nerve injury

Exclusion Criteria:

  • Use of systemic steroids (glucocorticoids) for treatment of any diagnoses
  • Known allergy to Polyethylene glycol
  • Actively Pregnant or Breastfeeding
  • Currently participating in other clinical trials

What do you need to know?

Participation in research is entirely voluntary. If you think you qualify to be part of this study, ask your doctor about participation.

Contact us if you are eligible and interested in this study

Please contact Lexie Reissaus, Clinical Research Manager at lreissaus@ihtsc.com.

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