Peripheral Nerve Injury Digital Nerve Hand Clinical Trial
Official title:
A Pilot Study to Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide
The goal of this study is to ascertain the feasibility and safety of the procedure using SilkBridge - a biocompatible silk fibroin-based scaffold - for the regeneration of sensory nerve fibres and follow it up together with the reinnervation of the target organs (sensory receptors in the skin).
This is a pre-market, monocentre, first-in-human pilot on adult patients with digital nerve
defects. Category C clinical trial, medical devices. The study will be performed in
Switzerland.
SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own
cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor
biological/chemical treatments.
SilkBridge will provide surgeons with an implant with unique features, such as easy
suturability, full biocompatibility and specific biomimetic properties that enhance cells
adhesion and integration of the device with the surrounding tissue.
The study will have a 12 months and 1 week duration per patient, including the follow-up
period, and with an expected enrollment period of 15 months.
The study will evaluate 15 adult patients, aged 18-65 years, diagnosed with digital nerve
defects (> 5 mm gap) in whom surgical repair may not allow direct suture.
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