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Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)

Prevalence Study of Amyloidosis in Patients With Surgery of Suspect Bilateral Carpal Tunnel (AMYLYONCARP)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04890119
Acronym
AMYLYONCARP
Enrollment
100
Registered
2021-05-18
Start date
2021-05-17
Completion date
2024-09-30
Last updated
2023-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome Bilateral

Brief 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

Interventions

DIAGNOSTIC_TESTtenosynovial tissue biopsy

Biopsy of tenosynovial tissue during surgery for amyloid aggregate search

Sponsors

Centre Hospitalier Saint Joseph Saint Luc de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* patient with diagnosis of amyloidosis * traumatic bilateral carpal tunnel or linked to rheumatoid arthritis

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of amyloid aggregateDuring surgeryResearch of amyloid aggregate in tenosynovial tissue

Secondary

MeasureTime frameDescription
Typing of amyloid aggregateDuring surgeryCaracterization of amyloid aggregate in tenosynovial tissue

Other

MeasureTime frameDescription
Research of organ amyloidosis (context of standard care): exploratoryin the 3 months following surgeryAmong positive patients, additional exams will be performed in the context of standard care in order to research for organ amyloidosis: blood sampling, EKG, echocardiography and other organ exams according to type of amyloidosis

Countries

France

Contacts

Primary ContactPhilippe SCHIELE, MD
pschiele@chsjsl.fr478 618 216
Backup ContactLisa GREEN, MD
lgreen@chsjsl.fr478 618 602

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026