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NCT05793320

Carpal Tunnel Release With Risk Factors for Amyloidosis

Status unknown NA Last updated 7 November 2023
What this trial tests

NA trial testing Carpal Tunnel Release Surgery in Amyloidosis in 250 participants. Status unknown.

Timeline
3 August 2023
Primary endpoint
3 August 2024
3 December 2024

Quick facts

Lead sponsorHenry Ford Health System
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment250
Start date3 August 2023
Primary completion3 August 2024
Estimated completion3 December 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Henry Ford Health System — full company profile →

Who can join

50 and older, any sex, with Amyloidosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Bilateral carpal tunnel syndrome has been demonstrated in previous literature to be a warning sign for potential amyloidosis. One study has been performed in which patients with bilateral carpal tunnel syndrome underwent tissue biopsy (either tendon sheath or transverse carpal ligament) at the time of carpal tunnel release to determine the strength of association as well as most common subtypes. However, no study has been done demonstrating whether or not patients with amyloid-positive carpal tunnel biopsy would benefit from an early referral to cardiology for a work-up of potential cardiac amyloidosis. In our study, patients with bilateral carpal tunnel symptoms who are indicated for carpal tunnel release would be identified in clinic and undergo biopsy for congo red staining at the time of surgery. All patients with positive biopsy results would be referred to cardiology. Outcomes would include the rate of amyloid positivity, common subtypes, and echocardiographic findings after cardiac referral.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Value of Early Diagnosis and Treatment of Amyloidosis: A Pilot Study of Synovial Biopsy During Carpal Tunnel Release.
    Ruesch T, Khurana N, Hansen L, Barkho K, et al · · 2025 · PMID 40741514 · DOI 10.1016/j.jhsg.2025.100779

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Other recruiting trials for Amyloidosis

Currently open trials in the same condition.

Other Henry Ford Health System trials

Trials by the same sponsor.

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Data sources for this page

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