NeuraGen 3D Pilot Study

NCT05343143 | Terminated FDA Device

• 1 other identifier: T-NERVE3D-001
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 4

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.

Conditions

Digital Nerve Injury

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to evaluate return to sensory recovery with the NeuraGen 3D Nerve Guide Matrix in a small group of subjects with primary nerve injury of the hand.(s2PD) at each post-operative timepoint of the study.

  To be assessed during in office visits using the DeMayo 2-point discrimination device

  12 Months

Secondary Outcomes (7)

• Moving 2 Point Discrimination Test (m2PD) at each post-operative timepoint of the study:

  12 Months

• Grip Strength Test at each post-operative timepoint of the study

  12 Months

• Pinch Strength Test at each post-operative timepoint of the study

  12 Months

• Semmes-Weinstein Monofilament Testing at each post-operative timepoint of the study

  12 Months

• Disabilities of the Arm, Shoulder and Hand (DASH) Score at each post-operative timepoint of the study

  12 Months

Study Arms (1)

NeuraGen 3D Nerve Guide Matrix

OTHER

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

Device: NeuraGen 3D Nerve Guide Matrix

Interventions

NeuraGen 3D Nerve Guide Matrix DEVICE

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

NeuraGen 3D Nerve Guide Matrix

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (4)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Duke University

Durham, North Carolina, 27708, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Study Officials

• Maria Leonard

  Integra LifeSciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: single arm investigational clinical trial

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 25, 2022
• Study Start: May 15, 2022
• Primary Completion: July 11, 2023
• Study Completion: May 13, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

US (4)