Neurogenic Thoracic Outlet SyndromeFIRSTNCT06172101
Free Fat Flap In Recurrent Neurogenic Thoracic Outlet Syndrome Surgical Treatment
An observational study of Neurogenic Thoracic Outlet Syndrome, run by Nantes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Thoracic Outlet Syndrome
- What is being tested?
- Free fat flap
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2023to 18 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients operated on for brachial plexus neurolysis and free fat flap coverage in the setting of recurrent neurological thoracic brachial outlet syndrome.
Who may be able to join
- Patients underwent brachial plexus neurolysis and free fat flap coverage in the context of recurrence of neurological thoraco-brachial outlet syndrome
Who cannot join
- Patients were unable to express their non-opposition to participating in the study.
- patients under guardianship or trusteeship.
- patients whose mother tongue is not French.
- patients who cannot read and/or write.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Evaluation of Improvement in Pain and Quality of Life After Free Fat Flap for Treatment of Recurrent Neurological Thoracobrachial Outlet Syndrome
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.
- Conditions
- Neurogenic Thoracic Outlet Syndrome
- Being tested
- Free fat flap
- Keywords
- Recurrent neurogenic thoracic outlet syndrome, Free fat flap
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free fat flapOther
Free fat flap In Recurrent neurogenic thoracic outlet syndrome Surgical Treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating the impact on pain of covering the brachial plexus with a free fat flap
the percentage reduction in pain assessed by a numerical scale from 0 to 10
Measured: pre-op and six months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start18 Dec 2023
- Primary completion18 May 2026 (estimated)
- Study completion18 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172101
- Sponsor's protocol ID
- AP_UL_001
- Acronym
- FIRST
- Status last verified
- Jul 2024
- First submitted
- 7 Dec 2023
- Last updated
- 19 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Improvement in Pain and Quality of Life After Free Fat Flap for Treatment of Recurrent Neurological Thoracobrachial Outlet Syndrome
- ClinicalTrials.gov ID
- NCT06172101
- Acronym / sponsor ID
- FIRST / AP_UL_001
- Conditions
- Neurogenic Thoracic Outlet Syndrome
- Keywords
- Recurrent neurogenic thoracic outlet syndrome, Free fat flap
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- 18 May 2026 (estimated)
- Study completion
- 18 May 2026 (estimated)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients operated on for brachial plexus neurolysis and free fat flap coverage in the setting of recurrent neurological thoracic brachial outlet syndrome.
Key inclusion criteria (1 listed)
- Patients underwent brachial plexus neurolysis and free fat flap coverage in the context of recurrence of neurological thoraco-brachial outlet syndrome
Key exclusion criteria (4 listed)
- Patients were unable to express their non-opposition to participating in the study.
- patients under guardianship or trusteeship.
- patients whose mother tongue is not French.
- patients who cannot read and/or write.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free fat flapFree fat flap In Recurrent neurogenic thoracic outlet syndrome Surgical Treatment | Other | – |
Primary outcome
Evaluating the impact on pain of covering the brachial plexus with a free fat flap
Time frame: pre-op and six months post-op
the percentage reduction in pain assessed by a numerical scale from 0 to 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Thoracic Outlet Syndrome, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ugo Lancien, M.D (+33 2 40 08 73 04, ugo.lancien@ch-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating the impact on pain of covering the brachial plexus with a free fat flap (time frame: pre-op and six months post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.