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Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

NCT03584022 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-01

No results posted yet for this study

Summary

This is safety study. Subjects will be undergoing the surgical procedure of nerve biopsy. After routine surgery without grafting, patients develop swelling, redness, tenderness and dysesthesia at the biopsy site. In order to determine whether grafting is safe compared to not repairing the nerve, it is necessary to compare treated vs. untreated patients using systematic, sensitive and reproducible criteria.

Conditions

  • Peripheral Neuropathy
  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy
  • Vasculitic Neuropathy (Disorder)
  • Amyloidosis
  • Hereditary Neuropathy
  • Sarcoid Neuropathy

Interventions

DEVICE

Biopsy + Nerve Repair

During the standard sural nerve biopsy procedure, a single-use, biodegradable implant designed to repair damaged peripheral nerves will be used to repair the nerve. The MCNS1 is a hollow nerve tube made of poly(caprolactone-fumarate) (PCLF), to connect severed nerve ends and promote the growth of regenerating axons.

PROCEDURE

Biopsy Only

Standard sural nerve biopsy only, without nerve repair.

Sponsors & Collaborators

Principal Investigators

  • Anthony J Windebank, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03584022 on ClinicalTrials.gov