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NCT07644325Recruiting

Concordance for Transthyretin Amyloidosis Between Synovial Biopsy and Anterior Carpal Ligament Biopsy

Assessment of Diagnostic Concordance for Transthyretin Amyloidosis Between Synovial Biopsy and Anterior Carpal Ligament Biopsy in Patients Who Underwent Endoscopic Carpal Tunnel Syndrome Surgery

Source: ClinicalTrials.gov · Last updated 12 Jun 2026

Brief summary (registry, in English)

Transthyretin amyloidosis (ATTR) is an underdiagnosed condition that can present early as carpal tunnel syndrome, sometimes preceding cardiac involvement by several years. The recent emergence of new treatments underscores the importance of early diagnosis. Synovial biopsy performed during open carpal tunnel surgery is considered the gold standard for local screening, but it is less accessible, more difficult, and riskier to perform via endoscopy-a minimally invasive surgical technique that is currently the standard at our center and is becoming increasingly widespread. The anterior annular ligament of the carpus constitutes an alternative tissue to the synovium, easily accessible via endoscopy, safe, and standardizable. In this study, the systematic performance of an annular ligament biopsy in conjunction with a synovial biopsy during endoscopic carpal tunnel surgery would allow for the evaluation of the diagnostic concordance of the ligament biopsy by comparing it to the results obtained using the gold standard method. This strategy would also provide an opportunity to analyze the feasibility of systematic screening for ATTR on the ligament during endoscopic procedures. This approach could offer a practical and innovative method for the early identification of at-risk patients and facilitate appropriate and timely management of the condition.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
500 (estimated)
First submitted
1 Jun 2026
Start date
27 May 2026
Primary completion date
27 May 2027
Lead sponsor
Clinique Saint Jean, France
Diseases
Amyloidosis
NCT number
NCT07644325

What you commit to

  • Study type: Interventional
  • Planned participants: 500
  • From 27 May 2026 to the primary completion date, 27 May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Need for open carpal tunnel surgery.

Other

  • Pregnant women
  • Adults under guardianship

Who the study is looking for

  • Adult patient with Health Insurance
  • Clinical diagnosis + carpal tunnel EMG
  • Validated indication for carpal tunnel surgery
  • Signed informed consent
  • Patient at risk for postoperative complications (bilateral carpal tunnel syndrome, heart failure, atrial fibrillation, elderly patients)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinique St Jean Sud de france
Coordinator of this site? Confirm its status
MontpellierFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.