NeuraGen 3D Pilot Study

NCT ID: NCT05343143

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2024-05-13

Brief Summary

This is a 10-subject, 12-month follow-up, prospective, multi-center, open-label, single arm clinical trial designed to understand the initial performance characteristics and confirm the safety profile of the NeuraGen 3D Nerve Guide Matrix.

Detailed Description

The NeuraGen® 3D Nerve Guide Matrix is indicated for the repair of peripheral nerve discontinuities where tension-free closure can be achieved by flexion of the digit or extremity.

Conditions

Digital Nerve Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NeuraGen 3D Nerve Guide Matrix

Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps.

Group Type: OTHER

NeuraGen 3D Nerve Guide Matrix

Intervention Type: DEVICE

Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps.

Interventions

NeuraGen 3D Nerve Guide Matrix

Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject has one, single level, digital nerve injury that:
• Involves complete traumatic nerve section of the common or proper nerve of the palmar aspect of hand.
• Occurred less than and up to 21 days prior to the nerve repair surgery detailed in this protocol.
• In the opinion of the investigator, has a gap which can be easily closed without placing undue tension on the ends of the nerves with the device (i.e., the gap must be shorter than the maximum length of the device being used).
• Subject has adequate vascular perfusion of the target hand as assessed by the investigator
• Subject can accommodate immobilization of the injured hand post-operatively.
• Subject's contralateral hand is intact and of normal function.

Exclusion Criteria

• Nerve to be repaired is a mixed motor nerve
• Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.
• 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's hand injury or general physical presentation of the target hand is of a nature which would prevent adequate measurement of functional nerve healing assessments.
• Subject has gross contamination of the wound in which the nerve to be studied in this protocol resides (i.e., presence of glass, metal, other large debris).
• 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 active infection of the area around the nerve defect.
• Subject has unstable vital signs.
• Subject has a disorder known to affect the peripheral nervous system (PNS) such as:
• Subject has any systemic disease which may confound study results 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 hand or limb which may impact nerve healing or confound study results.
• Subject is pregnant (determined either by the subject's confirmation or a formal test).
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Integra LifeSciences Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Leonard

Role: STUDY_DIRECTOR

Integra LifeSciences

Locations

Hospital for Special Surgery

New York, New York, United States

Duke University

Durham, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

T-NERVE3D-001

Identifier Type: -

Identifier Source: org_study_id