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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
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
Study ID
Protocol Number: 20-1997
More information available at ClinicalTrials.gov: NCT04572906
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