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NCT Number: NCT07644325

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

    Time frame: up to 3 weeks

    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.

Secondary outcomes

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

    Time frame: Perioperative/Periprocedural

    To evaluate and describe the feasibility of routinely performing a biopsy of the anterior annular ligament of the carpus during endoscopic carpal tunnel surgery. Feasibility will be assessed by the proportion of procedures in which a biopsy specimen of the anterior annular ligament of the carpus can be successfully obtained and submitted for histopathological analysis during endoscopic carpal tunnel surgery.

  2. Safety Assessment of Ligament Biopsy

    Time frame: up to 24hours

    Assess the safety of ligament biopsy, particularly with regard to specific complications.

Study contacts

Contact information is provided by the study sponsor or research team.

Cecile Spirito

CONTACT

[email protected]

0033467413399

Sponsors and collaborators

Lead sponsor

Clinique Saint Jean, France

Other

Registry information

Official study title

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

Acronym: ATTR2026

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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