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

NCT ID: NCT04890119

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-17

Study Completion Date

2024-09-30

Brief Summary

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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

Detailed Description

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Conditions

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Carpal Tunnel Syndrome Bilateral

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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tenosynovial tissue biopsy

Biopsy of tenosynovial tissue during surgery for amyloid aggregate search

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Saint Joseph Saint Luc de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe SCHIELE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Saint Joseph Saint Luc

Locations

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Centre Hospitalier Saint Joseph Saint Luc

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Philippe SCHIELE, MD

Role: CONTACT

478 618 216 ext. +33

Lisa GREEN, MD

Role: CONTACT

478 618 602 ext. +33

Facility Contacts

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Stéphane Rio

Role: primary

Other Identifiers

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AMYLYONCARP

Identifier Type: -

Identifier Source: org_study_id

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