NCT07644325 Concordance for Transthyretin Amyloidosis Between Synovial Biopsy and Anterior Carpal Ligament Biopsy
| NCT ID | NCT07644325 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Clinique Saint Jean, France |
| Condition | Carpal Tunnel |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-05-27 |
| Primary Completion | 2027-05-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2026-05-27 with a primary completion date of 2027-05-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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) Exclusion Criteria: * Need for open carpal tunnel surgery. * Pregnant women * Adults under guardianship
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07644325 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carpal Tunnel. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07644325 currently recruiting?
Yes, NCT07644325 is actively recruiting participants. Contact the research team at cecile.spirito@capsante.fr for enrollment information.
Where is the NCT07644325 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT07644325 clinical trial?
NCT07644325 is sponsored by Clinique Saint Jean, France. The trial plans to enroll 500 participants.