NeuraGen 3D Pilot Study

An Open-Label, Multicenter, Pilot Study to Evaluate the Performance and Safety of NeuraGen® 3D Nerve Guide Matrix.

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.

Study Overview

• Status: Terminated
• Conditions: Digital Nerve Injury
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
  • North Carolina
    • Durham, North Carolina, United States, 27708
      • Duke University
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Subjects with primary nerve injury of the hand

Description

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NeuraGen 3D Nerve Guide Matrix; Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps.	Device: NeuraGen 3D Nerve Guide Matrix; Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Moving 2 Point Discrimination Test (m2PD) at each post-operative timepoint of the study:	To be assessed during in office visits using the DeMayo 2-point discrimination device	12 Months
Grip Strength Test at each post-operative timepoint of the study	To be assessed during in office visits using the Camry hand dynamometer	12 Months
Pinch Strength Test at each post-operative timepoint of the study	To be assessed during in office visits using the Baseline Digital Pinch Gauge	12 Months
Semmes-Weinstein Monofilament Testing at each post-operative timepoint of the study	To be assessed during in office visits using the Baseline Tactile Semmes-Weinstein monofilament	12 Months
Disabilities of the Arm, Shoulder and Hand (DASH) Score at each post-operative timepoint of the study	To be completed via in office visits	12 Months
Michigan Hand Outcomes Questionnaire (MHQ) at each post-operative timepoint of the study	To be completed via in office visits	12 Months
Continuous Visual Analog Scale for Pain at each post-operative timepoint of the study	0-100 Scale, 0-no pain at all, 100- worst possible pain. To be completed via in office visits	12 Months

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Study Director: Maria Leonard, Integra LifeSciences

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Actual): July 11, 2023
• Study Completion (Actual): May 13, 2024

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: T-NERVE3D-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes