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

NCT07644325 | Recruiting

• 1 other identifier: 2026-A00378-43
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel; Transthyretin Amyloidosis

Outcome Measures

Primary Outcomes (1)

• agreement between the gold standard and the diagnosis based on examination of the open anterior annular ligament of the carpus for the detection of amyloid deposits during carpal tunnel surgery.

  To assess the agreement between the gold standard (synovial biopsy) and the diagnosis based on examination of the open anterior annular ligament of the carpus for the detection of amyloid deposits during carpal tunnel surgery.

  up to 3 weeks

Secondary Outcomes (2)

• Assessment and description of the feasibility of routinely performing a biopsy of the anterior annular ligament of the carpus during endoscopic carpal tunnel surgery.

  Perioperative/Periprocedural

• Safety Assessment of Ligament Biopsy

  up to 24hours

Study Arms (1)

Annular ligament biopsy in conjunction with a synovial biopsy

OTHER

For all patients, systematic performance of an annular ligament biopsy in conjunction with a synovial biopsy during the surgery

Diagnostic Test: Annular ligament biopsy

Interventions

Annular ligament biopsy DIAGNOSTIC_TEST

In addition to the standard synovial biopsy, a biopsy of the annular ligament of the carpus will be performed during endoscopic carpal tunnel surgery

Annular ligament biopsy in conjunction with a synovial biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Need for open carpal tunnel surgery.
• Pregnant women
• Adults under guardianship

Sponsors & Collaborators

• Clinique Saint Jean, France: lead

Study Sites (1)

Clinique St Jean Sud de france

Montpellier, 34430, France

RECRUITING

MeSH Terms

Conditions

Median Neuropathy; Amyloidosis, Hereditary, Transthyretin-Related

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Cecile Spirito

CONTACT

0033467413399; cecile.spirito@capsante.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 12, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): May 27, 2027
• Study Completion (Estimated): May 27, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)