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

NCT07084207 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • MMI (Medical Microinstruments, Inc.)

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-18
Primary Completion
2026-12-18
Completion
2027-12-18

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07084207 on ClinicalTrials.gov