NCT04245098

Brief Summary

Carpal tunnel syndrome has been suggested to be an early sign of amyloidosi. The investigators will evaluate tissue samples obtained from patients undergoing carpal tunnel release surgery for amyloid.

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 Jan 2020

Typical duration 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

Study Start

First participant enrolled

January 8, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2023

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

January 22, 2020

Last Update Submit

January 27, 2020

Conditions

AmyloidosisCarpal Tunnel Syndrome

Keywords

carpal tunnel syndromeamyloidosis

Outcome Measures

Primary Outcomes (1)

  • Number of participants with amyloid deposits in patients undergoing carpal tunnel surgery

    Prevalence of amyloid deposits in biopsy in patients undergoing carpal tunnel syndrome surgery

    2 years

Secondary Outcomes (1)

  • Number of participants with cardiac involvement in echocardiogram

    2 years

Study Arms (1)

Amyloid

EXPERIMENTAL

Biopsy

Procedure: Carpal tunnel syndrome surgery

Interventions

Carpal tunnel syndrome surgeryPROCEDURE

Biopsy

Amyloid

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing carpal tunnel syndrome surgery

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maria Del Carmen Navarro-Saez

Sabadell, Barcelona, 08208, Spain

RECRUITING

MeSH Terms

Conditions

AmyloidosisCarpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesMedian NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Central Study Contacts

Maria del Carmen Navarro-Saez, M.D.

CONTACT

937 231 010mnavarros@tauli.cat

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 28, 2020

Study Start

January 8, 2020

Primary Completion

January 8, 2022

Study Completion

January 8, 2023

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)