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ACTIVE NOT RECRUITING
NCT03584022
NA

Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

Sponsor: Mayo Clinic

View on ClinicalTrials.gov

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.

Official title: A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2018-11-09

Completion Date

2027-03

Last Updated

2025-04-20

Healthy Volunteers

No

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.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States