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

Sponsored by Integra LifeSciences Corporation

About this trial

Last updated a year ago

Study ID

T-INVENT-001

Status

Terminated

Type

Observational [Patient Registry]

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

- 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

No

Exclusion Criteria

- 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.

Locations

Location

Status