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Tiny incision, big relief: new device could transform carpal tunnel surgery

NCT ID NCT07692074

Symptom relief Sponsor: Clinique Saint François, Nice, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests a new, less invasive way to perform carpal tunnel release using a device called the KeriKnife™. The goal is to see if this technique is safe and effective, with less pain and faster recovery than traditional surgery. Adults with severe carpal tunnel syndrome who need surgery may join. The study will track success and complications for 30 days after the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
KeriKnife™ device
What this could lead to
If successful, this technique could offer a less painful, faster-recovering alternative to traditional carpal tunnel surgery.
What could go wrong
This is a small, early-stage study with limited clinical data. Risks include nerve injury, infection, or need for reoperation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 74 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients over the age of 18 with severe carpal tunnel syndrome as determined by electromyography * No other concomitant condition affecting the hand * Surgical indication for median nerve release * Have signed an informed consent form * Be enrolled in a social security program or be a beneficiary of such a program Exclusion Criteria: * Contraindications to carpal tunnel surgery * Presence of a concomitant condition affecting the hand to be operated on * Secondary carpal tunnel syndrome (e.g., tumor, synovial cyst, anatomical malformation, post-traumatic sequelae) * History of carpal tunnel surgery on the affected hand * Associated neurological conditions (peripheral neuropathies, Amyotrophic Lateral Sclerosis, Charcot-Marie-Tooth, etc.) * Coagulation disorders or anticoagulant therapy that cannot be discontinued * Patients who are unable to give informed consent or cannot return for scheduled follow-up visits as required by the protocol

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Conditions

The condition(s) this trial relates to.

carpal tunnel syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Carpal tunnel syndrome (CTS)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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