NCT03584022

Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients will be evaluated for eligibility and then, after gaining informed consent, the surgical procedure will be scheduled. Baseline evaluations include physical/neurological examination, nerve conduction study and ultrasonography of the sural nerve, and testing for erythrocyte sedimentation rate, C-reactive protein and complete blood counts (with white blood cell differential). Surgery is done in an operating room under local or monitored anesthesia, depending on patient preference. An incision will be made above the ankle. Immediately after the surgery, the patient will repeat the baseline physical/neurological exams, and sural nerve ultrasonography. Participants will be evaluated either in the clinic or by phone on a regular basis and will be required to keep a journal and fill out symptom questionnaires for up to 12 months post-procedure. Development of a grade 4 local reaction at any time will fulfill criteria for review by the Data and Safety Monitoring Board (DSMB) for implant removal and definition as a failure.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-11-09
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2018-07-12
• Last updated: 2025-04-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study