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Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial
Sponsor: Mayo Clinic
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
Conditions
Interventions
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.
Biopsy Only
Standard sural nerve biopsy only, without nerve repair.
Locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, United States