NCT07084207

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

REGEN: A Prospective, Randomized, Open Label Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: MMI (Medical Microinstruments, Inc.) · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical nerve coaptation, following nerve injuries to the hand. This study will include participants with traumatic sensory nerve lesions of a finger nerve distal to the carpal tunnel who are treated with nerve suturing. The primary effectiveness endpoint is the two-point discrimination (2PD) test, at 6-months post index procedure. The primary safety endpoint is the intraoperative serious adverse event rate.

Conditions

• Nerve Injury
• Peripheral Nerve Injuries

Interventions

Type	Name	Description
DEVICE	Symani® Surgical System	Robotic-assisted surgery consists of participants who undergo nerve coaptation with the Symani Surgical System, according to the Instruction for Use (IFU). In order for the surgery to be considered a robotic assisted surgery, the participants must be randomized to the RAS group which will include: * Participants where all nerve coaptations were performed entirely with Symani. * Participants who underwent a hybrid procedure, where a coaptation was commenced using Symani but a switch to manual suturing occurred during the procedure
PROCEDURE	Manual Surgery	Manual surgery consists of participants who undergo nerve coaptation through manual techniques by a surgeon using handheld instruments without robotic assistance. In order for the surgery to be considered a manual surgery, the participants must be randomized to the MS group which will include: * Participants where all nerve coaptations were performed entirely manually. * Participants who underwent a hybrid procedure, where a coaptation was commenced using manual suturing but a switch to Symani occurred during the procedure.

Timeline

• Start date: 2025-12-18
• Primary completion: 2026-12-18
• Completion: 2027-12-18
• First posted: 2025-07-24
• Last updated: 2026-02-03

Locations

1 site across 1 country: Germany