Study to Evaluate the Symani Surgical System for Repairing Peripheral Nerve Injuries in the Hand

What this Trial Is About

Researchers are evaluating the Symani Surgical System for safety and effectiveness in repairing sensory nerve injuries in the fingers. This study focuses on adults aged 18 to 70 with traumatic nerve damage distal to the carpal tunnel, treated by nerve suturing. The main goal is to assess nerve function recovery using the two-point discrimination test six months after surgery, while also monitoring serious events during the operation. Participants will be randomly assigned to one of two groups one receiving nerve repair with the robotic-assisted Symani Surgical System and the other undergoing manual nerve suturing by a surgeon. Both groups include participants who may have hybrid procedures combining robotic and manual techniques. Surgery must occur within 10 days of injury, and the study includes follow-up assessments up to 12 months post-procedure. During the study, participants will return for multiple evaluations measuring nerve sensitivity, hand and thumb strength, finger motion, and functional hand use at 3, 6, and 12 months after surgery. Safety is monitored by tracking serious adverse events during surgery. Overall, the study aims to understand how well robotic-assisted surgery compares to manual surgery for peripheral nerve repair, with participant involvement lasting at least one year after the operation.

A Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair