Carpal Tunnel Syndrome BilateralAMYLYONCARPNCT04890119
Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)
A study testing tenosynovial tissue biopsy in people with Carpal Tunnel Syndrome Bilateral, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon at 1 site in France.
Trial summary
The purpose of this study is to evaluate the prevalence of amyloidosis in population of patient affected by suspect bilateral carpal tunnel with indication of surgery Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome Bilateral
- What is being tested?
- tenosynovial tissue biopsy
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 17 May 2021to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- bilateral carpal tunnel with indication of surgery and judged suspect:
- age of 50 years old and more
- non-traumatic or undetermined neuropathic etiology or cardiac history (atrial arrhythmia or Heart Failure or cardiac stimulation) or family history of hereditary amyloidosis or monoclonal gammopathy
Who cannot join
- patient with diagnosis of amyloidosis
- traumatic bilateral carpal tunnel or linked to rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Saint Joseph Saint Luc
Lyon, 69007
Stéphane Rio, srio@chsjsl.fr
Philippe SCHIELE, MD
About this study
The purpose of this study is to evaluate the prevalence of amyloidosis in population of patient affected by suspect bilateral carpal tunnel with indication of surgery
- Conditions
- Carpal Tunnel Syndrome Bilateral
- Being tested
- tenosynovial tissue biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tenosynovial tissue biopsyDiagnostic test
Biopsy of tenosynovial tissue during surgery for amyloid aggregate search
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of amyloid aggregate
Research of amyloid aggregate in tenosynovial tissue
Measured: During surgery
Secondary outcomes (1)
Typing of amyloid aggregate
Caracterization of amyloid aggregate in tenosynovial tissue
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start17 May 2021
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel Syndrome BilateralStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe SCHIELE, MD, Principal investigator, Centre Hospitalier Saint Joseph Saint Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890119
- Sponsor's protocol ID
- AMYLYONCARP
- Acronym
- AMYLYONCARP
- Status last verified
- May 2023
- First submitted
- 6 May 2021
- Last updated
- 16 May 2023
- 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 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)
- ClinicalTrials.gov ID
- NCT04890119
- Acronym / sponsor ID
- AMYLYONCARP / AMYLYONCARP
- Conditions
- Carpal Tunnel Syndrome Bilateral
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Saint Joseph Saint Luc de LyonUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 18 May 2021 (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.
The purpose of this study is to evaluate the prevalence of amyloidosis in population of patient affected by suspect bilateral carpal tunnel with indication of surgery
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- bilateral carpal tunnel with indication of surgery and judged suspect:
- age of 50 years old and more
- non-traumatic or undetermined neuropathic etiology or cardiac history (atrial arrhythmia or Heart Failure or cardiac stimulation) or family history of hereditary amyloidosis or monoclonal gammopathy
Key exclusion criteria (2 listed)
- patient with diagnosis of amyloidosis
- traumatic bilateral carpal tunnel or linked to rheumatoid arthritis
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 |
|---|---|---|
| tenosynovial tissue biopsyBiopsy of tenosynovial tissue during surgery for amyloid aggregate search | Diagnostic test | – |
Primary outcome
Prevalence of amyloid aggregate
Time frame: During surgery
Research of amyloid aggregate in tenosynovial tissue
1 secondary outcome
Typing of amyloid aggregate
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
Related trials for Carpal Tunnel Syndrome Bilateral
Not yet recruiting
Early Screening for Cardiac Amyloid Using a History of Bilateral Carpal Tunnel Syndrome
Bilateral Carpal Tunnel Syndrome (Diagnosis), Cardiac Amyloidosis
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. This study is not recruiting at the moment.
Philippe SCHIELE, MD principal investigator
Centre Hospitalier Saint Joseph Saint Luc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tenosynovial tissue biopsy in people with Carpal Tunnel Syndrome Bilateral, run by Centre Hospitalier Saint Joseph Saint Luc de Lyon 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 May 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe SCHIELE, MD (478 618 216 ext. +33, pschiele@chsjsl.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of amyloid aggregate (time frame: During surgery). 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 16 May 2023.