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Tiny incision, big relief? study tests Ultrasound-Guided carpal tunnel release

NCT ID NCT04504019

Symptom relief Sponsor: Walter Reed National Military Medical Center 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two types of carpal tunnel release surgery: one using ultrasound guidance with a tiny incision (less than 1 cm) and the traditional mini-open method with a slightly larger cut. Forty-one adults with carpal tunnel syndrome were randomly assigned to one of the two procedures. Researchers tracked symptoms, hand strength, pain, and recovery time over 24 months to see if the ultrasound-guided approach works just as well and allows a quicker return to daily activities.

What this could mean

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

Active substance
SX-One MicroKnife (UltraGuideCTR) for ultrasound-guided carpal tunnel release
What this could lead to
If successful, this could show that ultrasound-guided carpal tunnel release is as effective as traditional surgery, with a smaller incision and possibly faster recovery.
What could go wrong
This is a small, single-site trial with only 41 participants, so results may not apply to everyone. The ultrasound-guided technique is still relatively new, and long-term outcomes beyond 24 months are not studied.

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

41 people

The number who actually took part.

Started

Mar 2021

Finished

Aug 2025

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 to 89 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Adults age ≥18 years * DEERS Eligible * Fluent in speaking, reading, and understanding English * Clinical diagnosis of Carpal Tunnel Syndrome (CTS) * Candidate for surgical CTR based on severe and/or refractory symptoms * Confirmatory electrodiagnostic test indicating median neuropathy at the wrist (abnormal findings) * Ultrasound findings consistent with median nerve enlargement in the carpal tunnel Exclusion Criteria: * Previous carpal tunnel release or previous wrist surgery on the ipsilateral side * Carpal tunnel injection with corticosteroid within 6 weeks prior to anticipated study procedure * Previous traumatic injury to the median nerve or any of its branches on the ipsilateral side * History of medical condition that would preclude safe participation in study procedures (e. g. complex regional pain syndrome (CRPS), upper limb vascular disease (including thoracic outlet syndrome), Raynaud's phenomenon, etc.) * Inability to stop anticoagulation medications (Plavix, Coumadin/Warfarin, Xarelto), or unable to be bridged with Lovenox * Unable to understand and provide written informed consent * Contraindication to proceeding with USCTR based on diagnostic ultrasound (i.e. identification of anomalous anatomic structures such as transligamentous thenar motor branch or space occupying lesions within the carpal tunnel) * Electrodiagnostic evaluation of the carpal tunnel which indicates normal findings

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Conditions

The condition(s) this trial relates to.

carpal tunnel syndrome median nerve neuropathy

As listed by the trial registrant

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

Carpal tunnel

Contacts and locations

Locations

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20814, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.