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

Completed · Phase 2

Conditions studied: Peripheral Nerve Injuries

In brief

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.

Key facts

Study ID

NCT04572906

Run by

Neuraptive Therapeutics Inc.

People needed

51

Starts

2020-09-25

Expected to finish

2024-06-27

Last updated by the study team

2024-11-20

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The subject is at least 12 years of age and not older than 80.
• The subject has sustained a confirmed (intra-op assessment) single transected peripheral nerve injury.
• The subject's nerve injury is classified as Sunderland's Fourth and Fifth Degree (Class III)
• The subject's nerve injury is amenable to minimal or acceptable tension, in direct, end-to-end repair.
• The surgical repair will occur within 48 hours of injury.

You may not qualify if…

• The subject has a PNI with a segmental loss (gap) that cannot be repaired with minimal or acceptable tension.
• Other treatments known to affect the growth and/or physiology of the neural and vascular system.
• The nerve injury has vascular damage that cannot be repaired to provide adequate perfusion of the injured site.
• The subject is pregnant and/or is breastfeeding.
• The subject has a significant medical comorbidity precluding immediate repair.

Where it is running

• UF Health - University of FL - Gainesville — Gainesville, Florida, United States
• Orlando Health — Orlando, Florida, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana Hand to Shoulder Center — Indianapolis, Indiana, United States
• Curtis National Hand Center — Baltimore, Maryland, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Washington University — St Louis, Missouri, United States
• The Ohio State University Wexner Medical Center Hand and Upper Extremity Center — Columbus, Ohio, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Harborview Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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