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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

Study

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Description

NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of a severed nerves in patients between 16 and 65 years of age.

Details
Age

Child to Adult

Eligibility

16 - 65 yo; single transected peripheral nerve injury; surgery will take place within 48 hrs of injury

Type of Study

Treatment

Locations

Denver Health and Hospital Authority
University of Colorado Hospital

Principal Investigator
Kevin Lillehei,  MD

Kevin Lillehei, MD

Study ID

Protocol Number: 20-1997

More information available at ClinicalTrials.gov: NCT04572906

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