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

NANot yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 30, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

March 31, 2028

Conditions
Nerve InjuryPeripheral Nerve Injuries
Interventions
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."

Trial Locations (1)

Unknown

BG Klinik Ludwigshafen, Ludwigshafen

All Listed Sponsors
lead

MMI (Medical Microinstruments, Inc.)

INDUSTRY

NCT07084207 - A Study to Expand the Use of Symani® Surgical System for Peripheral Nerve Repair | Biotech Hunter | Biotech Hunter