Annular ligament biopsy during endoscopic carpal tunnel surgery to screen for transthyretin amyloidosis
Official 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
Run by Clinique Saint Jean, France · NCT07644325 · Data updated 2026-11-12
This study tests whether a biopsy of the annular ligament during carpal tunnel surgery can reliably indicate transthyretin amyloidosis and match the results of the standard synovial biopsy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Clinique Saint Jean, France Academic / other |
| Locations | 1 site (Montpellier) |
| Status | Recruiting |
| Started | May 27, 2026 |
| Main results expected | May 27, 2027 |
| Study ends | May 27, 2027 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT07644325 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults undergoing carpal tunnel surgery who have clinical and EMG-confirmed carpal tunnel syndrome and are at risk for postoperative complications, with informed consent.
✕Probably not a fit
Patients without ATTR or without concordant biopsy results may not experience a diagnostic benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Transthyretin amyloidosis (ATTR) can present as carpal tunnel syndrome years before heart involvement. This study compares annular ligament biopsy, obtained through endoscopic carpal tunnel surgery, with the traditional synovial biopsy to see how well they agree in diagnosing ATTR. It is conducted in patients already scheduled for carpal tunnel surgery who have appropriate risk factors and consent. The aim is to determine if the less invasive ligament biopsy can provide a comparable diagnostic signal to the standard tissue. Results could support broader, safer screening during routine carpal tunnel procedures.
Why it matters
Potential benefit: If successful, patients may receive earlier detection of ATTR through a routine surgical procedure with less invasive tissue sampling.
How similar studies have gone: Prior approaches using tissue biopsy for ATTR screening have shown diagnostic value; this study explores a novel, less invasive tissue source with uncertain concordance.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Clinique St Jean Sud de france
Montpellier, France Recruiting
Study contacts
- Study coordinator: Cecile Spirito
- Email: cecile.spirito@capsante.fr
- Phone: 0033467413399
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Acoramidis for ATTR-CM: Cardiac Imaging Study
This study tests whether acoramidis can improve heart structure and function in people with transthyretin amyloid cardiomyopathy.
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Long-term safety of eplontersen in adults with transthyretin amyloidosis, including those with prior liver transplant or severe liver impairment
This study will see if eplontersen remains safe over time for adults with transthyretin amyloidosis, including people who have had a liver transplant or have severe liver problems.
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Eplontersen exposure during pregnancy and breastfeeding: outcomes
This project collects reports to see if exposure to eplontersen during pregnancy or breastfeeding affects mothers, fetuses, or infants with transthyretin amyloidosis.
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Preventing transthyretin amyloidosis in young carriers of a genetic variant
This study is testing if a medication called acoramidis can help prevent transthyretin amyloidosis in young adults who carry a specific genetic variant that puts them at risk for the disease.
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Observing the natural course of transthyretin amyloidosis
This study is looking to see how transthyretin amyloidosis progresses over time in over 1,600 adults while also gathering information on how well treatments like eplontersen work.
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Characterizing wild-type transthyretin amyloidosis cardiomyopathy and its impact on quality of life
This study is trying to understand how wild-type transthyretin amyloidosis cardiomyopathy affects the quality of life for patients at different stages of the disease compared to healthy individuals.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.