RecruitingNAINTERVENTIONAL

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

This research study is investigating a new surgical tool, called the Symani® Surgical System, for fixing injured nerves in the hand, specifically in the fingers. When a nerve in your finger is damaged, it can lead to a loss of feeling. Doctors want to see if using the Symani® system is a safe and effective way to repair these nerves, compared to standard surgery. They will be looking at how well patients regain feeling in their fingers and checking for any unexpected problems during or after surgery. This study aims to find out if this new technology can help improve recovery for people with specific finger nerve injuries.

At a glance

Status

Recruiting

Phase

Sponsor

MMI (Medical Microinstruments, Inc.)

Enrolment target

100

Start

18 Dec 2025

Estimated completion

18 Dec 2027

Nerve Injury Peripheral Nerve Injuries

What is this study about?

This study is all about finding better ways to repair damaged nerves in the hand, particularly those in the fingers. If a nerve in your finger gets cut, it can cause problems like numbness or a complete loss of feeling. Doctors usually fix this by carefully stitching the ends of the nerve back together in a procedure called microsurgery.

This research is testing a new tool called the Symani® Surgical System. It's designed to help surgeons perform these very delicate operations. The study will compare how well people recover when their nerves are repaired using the Symani® system versus the usual manual surgery. The main goal is to see if the Symani® system is both safe to use and effective at helping people regain feeling in their fingers after an injury.

To figure this out, doctors will check two main things: first, how much feeling a person gets back in their finger six months after surgery. They use a special test for this. Second, they'll closely watch for any serious problems that might happen during the operation. By doing this, they hope to learn if the Symani® system could offer a good option for future patients needing nerve repair.

Key takeaways

Tests a new surgical system (Symani®) for finger nerve repair.
Compares it to traditional surgery for safety and effectiveness.
Focuses on regaining feeling in the injured finger.
Participation involves surgery and follow-up visits for about 6 months.
Aims to improve recovery for people with certain hand nerve injuries.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old who has recently had a specific type of nerve injury in your hand or finger. This injury must be a complete cut in a finger nerve that affects your sense of touch. Doctors will need to be able to fix this nerve by stitching the ends together, and the injury must have happened within the last 10 days.

There are also some reasons why you might not be able to join. For example, if you have other serious health problems, are pregnant, or are already taking part in another medical study that might affect the results. If you have a pacemaker, or if the injury involves more complex damage like broken bones, you won't be able to participate. Also, if you can't or don't want to give your permission to be part of the study, you won't be included.

During the operation itself, the doctors will double-check that your nerve injury is suitable for this type of repair – specifically, that there's no big gap in the nerve and that it can be stitched end-to-end to restore feeling.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Did you recently have a cut to a nerve in your finger that made you lose feeling?
Was your injury treated within the last 10 days?
Do you not have a pacemaker or other serious health problems that might affect the study?
Are you able and willing to attend follow-up appointments for six months?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would have an operation to repair your injured finger nerve. This operation would either use the new Symani® Surgical System or traditional hand surgery, as decided by your surgeon. You won't know which method you'll receive beforehand. After your surgery, you will need to attend several follow-up appointments over a period of about six months. During these visits, doctors will perform special tests, like checking the feeling in your finger (called a two-point discrimination test), to see how well your nerve is healing. They'll also monitor you for any side effects or complications. The total duration of your active involvement in the study will last until your 6-month check-up.

Potential risks and benefits

Potential benefits of taking part could include receiving advanced surgical techniques and close monitoring of your recovery, which might lead to a good outcome for your nerve repair. However, as with any surgery, there are potential risks, such as infection, bleeding, or the possibility that the nerve doesn't heal as expected. Participating in a study also means more appointments and tests than usual care. You have the full right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

BG Klinik Ludwigshafen
Verified postcode
Ludwigshafen, Germany· Recruiting

Common questions

What is the Symani® Surgical System?

It's a new system that helps surgeons perform very delicate operations, like repairing nerves in fingers.

What kind of injury is this study for?

It's for specific cuts to a nerve in your finger that cause you to lose feeling, and where the nerve can be stitched back together.

Will I get to choose which surgery I have?

No, the type of surgery (Symani® or standard) will be decided by the doctors as part of the study design.

How long will I be involved in the study?

You'll be involved for about six months after your surgery, attending regular check-up appointments.

What if I change my mind about participating?

You are free to leave the study at any time without it affecting your medical care.

How to find out more

Clinical Operations

clinical.ops@mmimicro.com 8336646276 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.