Thoracic Outlet SyndromeSKIPANCT04376177
Clinical Routine in Thoracic Outlet Syndrome
An observational study of Thoracic Outlet Syndrome, run by University Hospital, Angers at 1 site in France.
Trial summary
Transversal recording and analysis of investigations performed in patients referred for suspected thoracic outlet syndrome (TOS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Outlet Syndrome
- What is being tested?
- Ultrasound, angiography and questionnaires
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to Dec 2025
- How long will I take part?
- 1 Year
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All adult subjects referred for the diagnosis or follow up of TOS
Who may be able to join
- Absence of deny for the use of medical filesfor research purposes
Who cannot join
- Inability to understand the purpose of the database.
- Patient protected by law.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Angers, 49933
Pierre ABRAHAM, MD PhD, +33241353689, piabraham@chu-angers.fr
About this study
Official title: Evaluation Des Mesures Dopplers, Angiographiques, Radiographique Oximetriques, Plethysmographiques, Electromyographiques et Des Questionnaires Cliniques Des Patients adressés Pour Suspicion de Syndrome du défilé Thoraco-brachial
Transversal recording and analysis of investigations performed in patients referred for suspected thoracic outlet syndrome (TOS)
Read the detailed description
Patients will have recording on a database of all investigations that were eventually performed for the diagnosis or follow up of their disease, among which:
- Characteristics (Age, Gender height, weight, ongoing treatment ,
- professional activity, sports activity,
- Symptoms.
- Forearm and finger photoplethysmography (PPG) during provocative maneuvers of the upper limb
- Transcutaneous oxymetry (Tcpo2) recording
- Standard questionnaires (MASC, DASH, FS36)
- Doppler and ultrasound during provocative maneuvers of the upper limb
- Angiography during provocative maneuvers of the upper limb
- Electromyogram
- Standard X-ray
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- Ultrasound, angiography, questionnaires, Transcutaneous oximetry, plethysmography
- 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.
UltrasoundDiagnostic test
Echodoppler imaging of upper limbs performed by trained operators at rest and during provocative maneuvers for TOS diagnosis.
angiographyDiagnostic test
Angiography (arterial and/or venous) of upper limbs performed by trained operators at rest and during provocative maneuvers such for TOS diagnosis.
questionnairesDiagnostic test
Use of standard questionnaires (MASC, DASH, SF36) for the evaluation of upper limb symptoms self-completed by the patients at admission.
Transcutaneous oximetryDiagnostic test
Mesurement of transcutaneuos oxygen pressure on both forearms performed at rest and during provocative maneuversfor TOS diagnosis.
plethysmographyDiagnostic test
Photoplethysmography of the forearms or fingers performed at rest and during provocative maneuvers for TOS diagnosis
ElectromyogramDiagnostic test
Electromyography of the upper limbs with encoding of the physician for the presence or abnsence of signs of plexis compression (impairment of the response on C8 T1 erea
Standard X-RayDiagnostic test
Standard X-Ray performed for the research of apophysomegaly or additionnal cervical rib.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Thoracic outlet syndrome | Patients referred to the University Hospital of Angers for the diagnostis or follow-up of thoracic outlet syndrome Receives: Diagnostic Test: Ultrasound; Diagnostic Test: angiography; Diagnostic Test: questionnaires; Diagnostic Test: Transcutaneous oximetry; Diagnostic Test: plethysmography; Diagnostic Test: Electromyogram; Diagnostic Test: Standard X-Ray |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasound
Retrieval of ultrasound interpretation as recorded in the patients' file by the physician that performed the test
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Jan 2018
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pierre ABRAHAM, MD; PhD, Principal investigator, University and univerity hospital in Angers, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376177
- Sponsor's protocol ID
- 2020/17
- Acronym
- SKIPA
- Status last verified
- Jun 2021
- First submitted
- 2 May 2020
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hersant J, Lecoq S, Ramondou P, Feuilloy M, Abraham P, Henni S. Upper arm versus forearm transcutaneous oximetry during upper limb abduction in patients with suspected thoracic outlet syndrome. Front Physiol. 2022 Nov 8;13:1033137. doi: 10.3389/fphys.2022.1033137. eCollection 2022.
PubMed 36425296Hersant J, Ramondou P, Josse C, Lecoq S, Henni S, Abraham P. Quantitative analysis of venous outflow with photo-plethysmography in patients with suspected thoracic outlet syndrome. Front Cardiovasc Med. 2022 Oct 28;9:803919. doi: 10.3389/fcvm.2022.803919. eCollection 2022.
PubMed 36386307
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Des Mesures Dopplers, Angiographiques, Radiographique Oximetriques, Plethysmographiques, Electromyographiques et Des Questionnaires Cliniques Des Patients adressés Pour Suspicion de Syndrome du défilé Thoraco-brachial
- ClinicalTrials.gov ID
- NCT04376177
- Acronym / sponsor ID
- SKIPA / 2020/17
- Conditions
- Thoracic Outlet Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 6 May 2020 (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.
Transversal recording and analysis of investigations performed in patients referred for suspected thoracic outlet syndrome (TOS)
Detailed description
Patients will have recording on a database of all investigations that were eventually performed for the diagnosis or follow up of their disease, among which:
- Characteristics (Age, Gender height, weight, ongoing treatment ,
- professional activity, sports activity,
- Symptoms.
- Forearm and finger photoplethysmography (PPG) during provocative maneuvers of the upper limb
- Transcutaneous oxymetry (Tcpo2) recording
- Standard questionnaires (MASC, DASH, FS36)
- Doppler and ultrasound during provocative maneuvers of the upper limb
- Angiography during provocative maneuvers of the upper limb
- Electromyogram
- Standard X-ray
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Thoracic outlet syndrome | – | Diagnostic Test: Ultrasound, Diagnostic Test: angiography, Diagnostic Test: questionnaires, Diagnostic Test: Transcutaneous oximetry, Diagnostic Test: plethysmography, Diagnostic Test: Electromyogram, Diagnostic Test: Standard X-RayPatients referred to the University Hospital of Angers for the diagnostis or follow-up of thoracic outlet syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult subjects referred for the diagnosis or follow up of TOS
Key inclusion criteria (1 listed)
- Absence of deny for the use of medical filesfor research purposes
Key exclusion criteria (2 listed)
- Inability to understand the purpose of the database.
- Patient protected by law.
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 |
|---|---|---|
| UltrasoundEchodoppler imaging of upper limbs performed by trained operators at rest and during provocative maneuvers for TOS diagnosis. | Diagnostic test | Patients with Thoracic outlet syndrome |
| angiographyAngiography (arterial and/or venous) of upper limbs performed by trained operators at rest and during provocative maneuvers such for TOS diagnosis. | Diagnostic test | Patients with Thoracic outlet syndrome |
| questionnairesUse of standard questionnaires (MASC, DASH, SF36) for the evaluation of upper limb symptoms self-completed by the patients at admission. | Diagnostic test | Patients with Thoracic outlet syndrome |
| Transcutaneous oximetryMesurement of transcutaneuos oxygen pressure on both forearms performed at rest and during provocative maneuversfor TOS diagnosis. | Diagnostic test | Patients with Thoracic outlet syndrome |
| plethysmographyPhotoplethysmography of the forearms or fingers performed at rest and during provocative maneuvers for TOS diagnosis | Diagnostic test | Patients with Thoracic outlet syndrome |
| ElectromyogramElectromyography of the upper limbs with encoding of the physician for the presence or abnsence of signs of plexis compression (impairment of the response on C8 T1 erea | Diagnostic test | Patients with Thoracic outlet syndrome |
| Standard X-RayStandard X-Ray performed for the research of apophysomegaly or additionnal cervical rib. | Diagnostic test | Patients with Thoracic outlet syndrome |
Primary outcome
ultrasound
Time frame: 1 hour
Retrieval of ultrasound interpretation as recorded in the patients' file by the physician that performed the test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Derived from this study: PubMed 36425296Hersant J, Lecoq S, Ramondou P, Feuilloy M, Abraham P, Henni S. Upper arm versus forearm transcutaneous oximetry during upper limb abduction in patients with suspected thoracic outlet syndrome. Front Physiol. 2022 Nov 8;13:1033137. doi: 10.3389/fphys.2022.1033137. eCollection 2022.
- Derived from this study: PubMed 36386307Hersant J, Ramondou P, Josse C, Lecoq S, Henni S, Abraham P. Quantitative analysis of venous outflow with photo-plethysmography in patients with suspected thoracic outlet syndrome. Front Cardiovasc Med. 2022 Oct 28;9:803919. doi: 10.3389/fcvm.2022.803919. eCollection 2022.
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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.
Pierre ABRAHAM, MD; PhD principal investigator
University and univerity hospital in Angers, FRANCE
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 Thoracic Outlet Syndrome, run by University Hospital, Angers 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 2 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 3 Jun 2021. 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 pierre Abraham, MD PhD (+33241353689, piabraham@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasound (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04376177, which also lists 2 linked publications.
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 3 Jun 2021.