NCT03584022View on ClinicalTrials.gov

Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

NAActive, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

November 9, 2018

Primary Completion Date

March 31, 2027

Study Completion Date

March 31, 2027

Conditions
Peripheral NeuropathyChronic Inflammatory Demyelinating PolyradiculoneuropathyVasculitic Neuropathy (Disorder)AmyloidosisHereditary NeuropathySarcoid 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.

Trial Locations (1)

55905

Mayo Clinic in Rochester, Rochester

Sponsors

Lead Sponsor

Mayo Clinic
All Listed Sponsors
lead

Mayo Clinic

OTHER