NCT05339594

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

Post-Market Clinical Follow-up Registry of Patients Requiring Nerve Gap Repair From Integra

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 17 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Integra NeuraGen Nerve Guide has been approved for clinical use since 2001 and has become a recognized clinical option for clinical nerve repair for the type of injuries evaluated in this registry. Integra NeuraGen Nerve Guide is used in this registry as a comparator to a next-generation advanced nerve guide, Integra NeuraGen 3D Nerve Guide Matrix, that is based on the original Integra NeuraGen Nerve Guide technology but contains a regenerative matrix in the lumen. Centers chosen for participation will be current users of Integra's collagen nerve gap repair products listed above.

Conditions

• Peripheral Nerve Injuries

Interventions

Type	Name	Description
DEVICE	NeuraGen	NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps.
DEVICE	NeuraGen 3D	NeuraGen 3D Nerve guide matrix is a resorbable implant for the repair of peripheral nerve gaps.

Timeline

• Start date: 2022-05-30
• Primary completion: 2024-06-03
• Completion: 2024-06-03
• First posted: 2022-04-21
• Last updated: 2024-07-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study