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NCT06172101: FIRST

Free Fat Flap In Recurrent Neurogenic Thoracic Outlet Syndrome Surgical Treatment

Recruiting now Last updated 19 July 2024
What this trial tests

trial testing Free fat flap in Neurogenic Thoracic Outlet Syndrome in 20 participants. Currently enrolling.

Timeline
18 December 2023
Primary endpoint
18 May 2026
18 May 2026

Quick facts

Lead sponsorNantes University Hospital
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment20
Start date18 December 2023
Primary completion18 May 2026
Estimated completion18 May 2026
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Nantes University Hospital

Who can join

18 and older, any sex, with Neurogenic Thoracic Outlet Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The Thoraco-Brachial Outlet Syndrome (T-BOS) corresponds to the entirety of clinical manifestations related to the compression of the branches of the brachial plexus and/or the subclavian vessels during their passage through the cervico-thoracic region. Following surgery, a recurrence of symptoms occurs in 5% to 30% of operated patients. The treatment of these recurrences primarily relies on conservative therapies, and in case of failure, surgical intervention, particularly neurolysis of the brachial plexus. In order to prevent a new recurrence, it is desirable to cover the neurolyzed brachial plexus with a flap, providing better local vascularization. However, fatty perforating flaps, by avoiding muscle harvesting, reduce donor site sequelae. We aim to investigate, through validated and recommended questionnaires, the impact of covering the neurolyzed brachial plexus with a free fatty flap after neurolysis in the context of recurrent neurological Thoraco-Brachial Outlet Syndrome.

Publications & conference data

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

  1. Free fat flap transfer in recurrent neurogenic thoracic outlet syndrome pain treatment: FIRST observational pilot study.
    Thuau F, Gadbled G, Goronflot T, Perrot P, et al · · 2025 · PMID 40861285 · DOI 10.1097/sp9.0000000000000045

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