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Thousands tracked after carpal tunnel surgery: does new device deliver?

NCT ID NCT06071468

Knowledge-focused Sponsor: Sonex Health, Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times

Summary

This study is tracking 2000 adults with carpal tunnel syndrome who are having surgery to release the nerve. The surgery uses a special device called UltraGuideCTR, which is guided by ultrasound. Researchers are collecting real-world data on symptoms and hand function for up to 24 months 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
UltraGuideCTR device
What this could lead to
If successful, this registry could provide clear evidence on how well the UltraGuideCTR device works for carpal tunnel release in everyday practice.
What could go wrong
This is an observational registry, not a controlled trial, so results may not prove cause and effect. The device is already commercially available, so no breakthrough is expected.

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.

Participants

1,424 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Patients with Carpal Tunnel Syndrome meeting study eligibility criteria. Patients are invited to volunteer to participate at selected study sites.

Ages

18 years and older

Sex

Anyone

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 1. ≥18 years of age 2. Clinical diagnosis of unilateral or bilateral CTS 3. A clinical decision has been made to perform CTR on one or both hands 4. CTS-6 score ≥12 in the target hand(s)\* 5. Confirmatory diagnostic testing in the target hand(s)\*: 1. CTR-US: Confirmatory diagnostic testing with ultrasound (median nerve cross-sectional area ≥10 mm2 in the proximal carpal tunnel region) 2. ECTR or OCTR: Confirmatory electrodiagnostic testing 6. Prior failure of one or more nonsurgical treatment options (e.g., physical activity modification, bracing, splinting, corticosteroid injection) in the target hand(s) 7. Patient agrees to complete follow-up questionnaires over a 24-month period 8. Patient has a valid smart phone number and/or email address to receive and answer follow-up questionnaires Note: An asterisk (\*) denotes that this criterion must be applied to the target hand for unilateral CTR procedures, or to both hands for simultaneous bilateral CTR procedures. Exclusion Criteria: 1. Patient meets any of the contraindications per Instruction For Use (IFU) 2. Patient has other medical, social, or psychological conditions that, in the opinion of the investigator, preclude them from completing all registry requirements.

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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

Contacts and locations

Locations

  • Aventura Hand Center

    Aventura, Florida, 33180, United States

  • Buffalo Surgery Center

    Amherst, New York, 14226, United States

  • Cape Cod Orthopaedics

    Hyannis, Massachusetts, 02601-3825, United States

  • Dartmouth Hitchcock Clinic

    Lebanon, New Hampshire, 03756, United States

  • Excel Orthopaedic Specialists

    Woburn, Massachusetts, 01801, United States

  • Hand Center of Nevada

    Las Vegas, Nevada, 89123, United States

  • Lakeland Regional Health

    Lakeland, Florida, 74137, United States

  • Meadville Medical Center

    Meadville, Pennsylvania, 16335, United States

  • Melbourne Hand Center

    Melbourne, Florida, 32935, United States

  • Mendelson Orthopedic PC

    Troy, Michigan, 48080, United States

  • Miami Hand Center

    Miami, Florida, 33133, United States

  • Mississippi Sports Medicine& Orthopedic Center

    Jackson, Mississippi, 39202, United States

  • Mobility Bone and Joint Institute

    Salem, New Hampshire, 03079, United States

  • New Mexico Orthopedics

    Albuquerque, New Mexico, 87110, United States

  • North Texas Hand Center

    Denton, Texas, 76210, United States

  • North Texas Orthopedics and Spine Center

    Fort Worth, Texas, 76244, United States

  • OrthoSC

    Conway, South Carolina, 29526, United States

  • Orthopaedic Associates

    Fort Walton Beach, Florida, 32547, United States

  • Orthopaedics Associates of Hartford

    Glastonbury, Connecticut, 06033, United States

  • Orthopedic Asociates

    St Louis, Missouri, 63131, United States

  • Phoenix Hand

    Scottsdale, Arizona, 85260, United States

  • Prisma Health

    Greenville, South Carolina, 29615, United States

  • Slocum Research & Education Foundation

    Eugene, Oregon, 97401, United States

  • Sports Orthopedics & Spine

    Jackson, Tennessee, 38305, United States

  • The Bone&Joint Surgery Clinic

    Raleigh, North Carolina, 27609, United States

  • The Center

    Bend, Oregon, 97701, United States

  • The Orthopaedic Group P.C.

    Foley, Alabama, 36535, United States

  • The Orthopaedic Hand and Arm Center

    Miami Lakes, Florida, 33014, United States

  • Tri-State Orthopaedics

    Evansville, Indiana, 47715, United States

  • Twin Cities Orthopedics

    Edina, Minnesota, 55435, United States

  • University Orthopedics Center

    State College, Pennsylvania, 16801, United States

  • University Orthopedics, Inc.

    East Providence, Rhode Island, 02914, United States

  • Vero Orthopaedics

    Vero Beach, Florida, 32960, United States

More trials for these conditions

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