CClinicalTrials.gg
TerminatedNCT07668310EPECUpdated Jul 16, 2026

Effectiveness of PErcutaneous Ultrasound-guided Carpal Tunnel Release: a Non-inferiority Study With Surgery as Comparator

An interventional study of Carpal tunnel surgery and Questionnaires in Carpal Tunnel Syndrome (CTS), sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by GCS Ramsay Santé pour l'Enseignement et la Recherche · Not applicable, Interventional, and Other

Why this study was terminated
Investigator's illness and recrutement difficulties

From the registry’s dates

  • Registered 3 years 5 months after the study started (first participant enrolled Jan 2023, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
7
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Carpal tunnel syndrome is a common condition caused by compression of the median nerve. Tingling in the first three or four fingers, usually at night or upon waking, is the most frequent symptom. Reduced sensation in the fingers and clumsiness can also occur, and in severe cases, there may even be weakness in thumb abduction with thenar muscle wasting. Carpal tunnel syndrome (CTS) is the most commonly diagnosed nerve compression syndrome. The annual incidence of diagnosis varies depending on the study and the country. It's estimated at 3.8 per thousand in the general population, 1 to 2 per thousand in men, 4 to 5 per thousand in women, with a peak between ages 40 and 60.

Medical treatment combines removing a microtraumatic factor, immobilization with a brace, and giving 1 to 2 cortisone injections into the carpal tunnel. The results are good in purely sensory cases. If it doesn't work, things get worse despite treatment, or in severe cases from the start (severe sensory problems, loss of strength, muscle wasting), surgery is recommended.

Several teams have recently demonstrated the benefits of using a minimally invasive ultrasound-guided surgical technique to perform flexor retinaculum sectioning under ultrasound guidance. This technique offers increased safety thanks to continuous ultrasound monitoring and the visualization of median nerve variants. Rojo et al. compared ultrasound surgery with a 1 mm incision to mini-open surgery with a 20 mm incision in 128 patients. This study suggests that a minimally invasive approach could allow for faster functional pain recovery compared to conventional surgery.

This project is based on the hypothesis that the proposed ultrasound-guided percutaneous release technique has an efficacy and tolerability profile suitable for widespread use in the indication of carpal tunnel syndrome resistant to conservative treatment, and that it can therefore reduce the need for conventional surgery in this indication.

02

Conditions studied

  • Carpal Tunnel Syndrome (CTS)
03

In context

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 140 are open to participants now.

This study's enrollment of 7 is below the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.

Browse Carpal Tunnel Syndrome studies →

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche is the lead sponsor of 198 studies on the registry; 94 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient, male or female, over 18 years of age
  • Patient with clinical carpal tunnel syndrome
  • Patient with unilateral or bilateral carpal tunnel syndrome. In the case of bilateral involvement, the more symptomatic hand (with the highest Boston score) will be included, with the patient agreeing that the second hand will not be operated on within one year.
  • Patient with carpal tunnel syndrome confirmed by an EMG less than 6 months old
  • Patient with carpal tunnel syndrome without motor or sensory deficits
  • Patient with carpal tunnel syndrome resistant to conservative treatment, including at least one corticosteroid injection
  • Patient agreeing to undergo surgery
  • Patient affiliated with or covered by a social security plan
  • Patient who has been informed and has signed a free and informed written consent.

Exclusion criteria

Exclusion Criteria:

  • Patient with another condition of the hand or wrist (Dupuytren's disease, inflammatory rheumatism, symptomatic osteoarthritis)
  • Patient with a history of previous hand or wrist surgery requiring treatment
  • Neurological sequelae of the hand
  • Patient with non-medicinal hypocoagulation or vitamin K antagonist overdose
  • Patient with a known allergy to lidocaine
  • Patient with an unhealed palmo-digital wound
  • Patient with a superficial or deep palmo-digital infection or inflammation
  • Patient who has received a cortisone injection in the hand or wrist within the last month. - Patient with type 1 diabetes or poorly controlled diabetes (HbA1c >7.5% for less than 3 months)
  • Patient with cognitive impairment deemed incompatible with the research by the investigator
  • Patient with a language barrier preventing a reliable assessment
  • Patient participating in another clinical trial
  • Protected patient: adult under guardianship, curatorship, or other legal protection, deprived of liberty by judicial or administrative decision
  • Pregnant, breastfeeding, or postpartum woman
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Patient undergoing percutaneous ultrasound-guided carpal tunnel release procedure.

    Procedure: Carpal tunnel surgery · Other: Questionnaires

  • Active comparator
    Patient undergoing conventional surgery.

    Procedure: Carpal tunnel surgery · Other: Questionnaires

Interventions

  • ProcedureCarpal tunnel surgery

    The aim of this study is to compare the conventional surgery to the percutaneous ultrasound-guided carpal tunnel release procedure. One group is doing the conventional surgery and the other the procédure to evaluate.

  • OtherQuestionnaires

    EVA, Boston and Quick Dash questionnaires : all study visits

06

What researchers measure

Primary outcomes

  1. Severity of symptoms" subscore of the Boston Questionnaire

    The "Severity of symptoms" subscore of the Boston Questionnaire, specific to carpal tunnel syndrome, 3 months post-intervention, assessed by the clinical research associate, blinded to the procedure performed. Eleven questions with a score between 1 and 5 for each items. The final score is between 11 (no symptoms) and 55 (very high severity).

    Time frame: 3 months after surgery

07

Study locations

1 site
  • Hôpital Lariboisière
    Paris, 75010, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07668310
Lead sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Responsible party
Sponsor
First posted
Jun 25, 2026
Start date
Jan 1, 2023
Primary completion
Mar 15, 2025
Completion
Mar 15, 2025
Last update
Jul 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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