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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
Phase
II - Research Studies that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Type of Study
Treatment
Locations
Denver Health and Hospital Authority
University of Colorado Hospital
Principal Investigator
Kevin Lillehei
Study ID
Protocol Number: 20-1997
More information available at ClinicalTrials.gov: NCT04572906
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