REINVENT Registry (Registry of the Nerve Gap Repair From Integra)

Stopped early

Conditions studied: Peripheral Nerve Injuries

In brief

This is a prospective, multi-center, observational registry designed to evaluate two of Integra's collagen nerve gap repair products (NeuraGen® Nerve Guide and NeuraGen® 3D Nerve Guide Matrix). This registry will collect data on the outcome measures throughout the follow-up period for each patient. Data will be collected per standard of care.

Key facts

Study ID: NCT05339594
Run by: Integra LifeSciences Corporation
People needed: 17
Starts: 2022-05-30
Expected to finish: 2024-06-03
Last updated by the study team: 2024-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject has undergone nerve gap repair utilizing NeuraGen or NeuraGen 3D
Subject is willing and able to comply with postoperative procedures and visits such as immobilization, etc.
Subject had a digital nerve injury that occurred up to 90 days prior to the nerve gap repair surgery detailed in this protocol.
Subject had digital nerve injury(ies) that involve(s) complete nerve section of a sensory nerve of the palmar aspect of the hand that is distal to the palmer crease of the hand.
Subject requires only a single repair per proper digital nerve branch

You may not qualify if…

Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
Subject has participated in another clinical trial using an investigational drug or device within 30 days prior to the nerve repair surgery detailed in this protocol.
Subject's hand injury is of a nature which could negatively impact healing of the target nerves such as a crush or avulsion injury, incomplete transection of the target nerve, or complete separation of the digit affiliated with the target nerve
Subject has debris due to injury of the affected hand where contamination cannot be ruled out.
Subject has pre-existing nerve lesions or known diagnosis of compressive neuropathy of median or ulnar nerves (i.e., Cubital or carpal tunnel syndrome)
Subject has an infection of the area around the nerve defect.
Subjects with diagnosed Peripheral Vascular Disease and Peripheral Arterial Disease
Subject is known to have received immunosuppressive or antineoplastic agents or systemic steroids within 7 days of the study.
Subject is known to have had or will require radiation or other therapy to the target hand or limb which may impact nerve healing.
Subject has a history of injury to or a congenital abnormality of the target or contralateral hand or limb which may impact nerve healing or confound study results.

Where it is running

Indiana Hand to Shoulder Center — Indianapolis, Indiana, United States
Washington University at St Louis — St Louis, Missouri, United States
Montefiore Medical Center — The Bronx, New York, United States
University of Pittsburgh Medical Center (UPMC) — Pittsburgh, Pennsylvania, United States
University of Virginia — Charlottesville, Virginia, United States
West Virginia University — Morgantown, West Virginia, United States

Full record on ClinicalTrials.gov

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