Carpal TunnelATTR2026NCT07644325
Concordance for Transthyretin Amyloidosis Between Synovial Biopsy and Anterior Carpal Ligament Biopsy
A study testing Annular ligament biopsy in people with Carpal Tunnel and Transthyretin Amyloidosis, run by Clinique Saint Jean, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel, Transthyretin Amyloidosis
- What is being tested?
- Annular ligament biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2026to 27 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Need for open carpal tunnel surgery.
- Pregnant women
- Adults under guardianship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique St Jean Sud de france
Montpellier, 34430
Cecile Spirito, 00304 67 41 34 53, cecile.spirito@capsante.fr
About this study
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
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.
Read more
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
- Being tested
- Annular ligament biopsy
- Medical subject headings
- Median Neuropathy, Amyloidosis, Hereditary, Transthyretin-Related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Annular ligament biopsyDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Annular ligament biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Perioperative/Periprocedural
Safety Assessment of Ligament Biopsy
Assess the safety of ligament biopsy, particularly with regard to specific complications.
Measured: up to 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start27 May 2026
- Primary completion27 May 2027 (estimated)
- Study completion27 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal TunnelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Jean, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644325
- Sponsor's protocol ID
- 2026-A00378-43
- Acronym
- ATTR2026
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07644325
- Acronym / sponsor ID
- ATTR2026 / 2026-A00378-43
- Conditions
- Carpal Tunnel, Transthyretin Amyloidosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Clinique Saint Jean, FranceUniversity, hospital or other
- Study start
- 27 May 2026 (actual)
- Primary completion
- 27 May 2027 (estimated)
- Study completion
- 27 May 2027 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Annular ligament biopsy in conjunction with a synovial biopsy | Other | Diagnostic Test: Annular ligament biopsyFor all patients, systematic performance of an annular ligament biopsy in conjunction with a synovial biopsy during the surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Need for open carpal tunnel surgery.
- Pregnant women
- Adults under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Annular ligament biopsyIn addition to the standard synovial biopsy, a biopsy of the annular ligament of the carpus will be performed during endoscopic carpal tunnel surgery | Diagnostic test | Annular ligament biopsy in conjunction with a synovial biopsy |
Primary outcome
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.
2 secondary outcomes
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
Safety Assessment of Ligament Biopsy
Time frame: up to 24hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Annular ligament biopsy in people with Carpal Tunnel and Transthyretin Amyloidosis, run by Clinique Saint Jean, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cecile Spirito (0033467413399, cecile.spirito@capsante.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.