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Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries

NCT04572906 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-11-20

No results posted yet for this study

Summary

NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 16 and 80 years of age.

Conditions

  • Peripheral Nerve Injuries

Interventions

COMBINATION_PRODUCT

NTX-001

One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy. An isolation chamber medical device (device) is utilized to focus the application of PEG (Solution #2) on the coapted nerve for the required amount of exposure time.

Sponsors & Collaborators

  • Neuraptive Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Seth Schulman, MD · Neuraptive Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-25
Primary Completion
2024-06-27
Completion
2024-06-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04572906 on ClinicalTrials.gov