NCT04890119

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

May 6, 2021

Last Update Submit

May 15, 2023

Conditions

Carpal Tunnel Syndrome Bilateral

Outcome Measures

Primary Outcomes (1)

  • Prevalence of amyloid aggregate

    Research of amyloid aggregate in tenosynovial tissue

    During surgery

Secondary Outcomes (1)

  • Typing of amyloid aggregate

    During surgery

Other Outcomes (1)

  • Research of organ amyloidosis (context of standard care): exploratory

    in the 3 months following surgery

Interventions

tenosynovial tissue biopsyDIAGNOSTIC_TEST

Biopsy of tenosynovial tissue during surgery for amyloid aggregate search

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Saint Joseph Saint Luc

Lyon, 69007, France

RECRUITING

Study Officials

  • Philippe SCHIELE, MD

    Centre Hospitalier Saint Joseph Saint Luc

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe SCHIELE, MD

CONTACT

478 618 216pschiele@chsjsl.fr

Lisa GREEN, MD

CONTACT

478 618 602lgreen@chsjsl.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2021

First Posted

May 18, 2021

Study Start

May 17, 2021

Primary Completion

June 1, 2024

Study Completion

September 1, 2024

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)