Clinical Trial

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

Study acronym: REGEN
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-16.
Status change: Not Yet Recruiting → Recruiting 2026-01-30
Trial Details
NCT Number NCT07084207
Lead Sponsor MMI (Medical Microinstruments, Inc.)
Conditions Nerve Injury, Peripheral Nerve Injuries
Enrollment 100 participants
Start Date 2025-12-18
Primary Completion 2026-12-18 (estimated)
Study Completion 2027-12-18 (estimated)
Updated on ClinicalTrials.gov 2026-02-03