Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-27 @ 4:37 PM
Study NCT ID:
NCT05702866
Status:
COMPLETED
Last Update Posted:
2023-01-27
First Post:
2023-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Compression Assessment Using Transcutaneous Oxymetry in Patients Suspected of Having Thoracic Outlet Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013901', 'term': 'Thoracic Outlet Syndrome'}], 'ancestors': [{'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001785', 'term': 'Blood Gas Monitoring, Transcutaneous'}], 'ancestors': [{'id': 'D010092', 'term': 'Oximetry'}, {'id': 'D001784', 'term': 'Blood Gas Analysis'}, {'id': 'D001774', 'term': 'Blood Chemical Analysis'}, {'id': 'D019963', 'term': 'Clinical Chemistry Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-26', 'studyFirstSubmitDate': '2023-01-18', 'studyFirstSubmitQcDate': '2023-01-26', 'lastUpdatePostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DROPmin according on the type of compression', 'timeFrame': 'thirty minutes', 'description': 'Variation in upper limb ischemia is estimated by TcpO2 measurement and calculating of the DROPmin (TcpO2 variation regarding a reference) depending on the type of damage (arterial, venous, or both arterial and venous).\n\nDROP is Decrease Rest of Oxygen Pressure'}], 'secondaryOutcomes': [{'measure': 'DROPmin according on the degree of arterial stenosis', 'timeFrame': 'thirty minutes', 'description': 'To assess the correlation between the severity of upper limb ischemia by TcpO2 measurement and the degree of arterial stenosis observed in diagnostic arteriography.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcutaneous oximetry', 'thoracic outlet syndrome', 'arteriography', 'vascular compression'], 'conditions': ['Thoracic Outlet Syndrome']}, 'descriptionModule': {'briefSummary': 'Thoracic outlet syndrome (TOS) is characterized by nervous, venous or arterial symptoms resulting from a compression of the thoracic bundle in the thoracic outlet. The diagnostic approach of TOS is still controversial. The investigating team is interested in arterial TOS and have already been able to demonstrate the presence of arm ischemia during dynamic maneuvers using transcutaneous oximetry (TcpO2). The correlation between the measurement of TcpO2 during dynamic maneuvers and the vascular compression type (arterial, venous or both) will be evaluated. The evaluation the correlation between TcpO2 and degree of arterial compression observed in dynamic arteriography (considered as a gold standard examination) will be calculated too. The use of TcpO2 could be developed in the diagnosis assessment of TOS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient presenting to the vascular medicine department with suspected thoracic outlet syndrome.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient suspected of having a thoracic outlet syndrome\n* patient having carried out additional examinations as part of the diagnostic assessment : venous and arterial Doppler or dynamic arteriography and venography\n* patient having carried out a dynamic TcpO2 recording\n\nExclusion Criteria:\n\n* patient under 18 year old\n* non french speaker\n* patient who expressed his/her refusal'}, 'identificationModule': {'nctId': 'NCT05702866', 'briefTitle': 'Vascular Compression Assessment Using Transcutaneous Oxymetry in Patients Suspected of Having Thoracic Outlet Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': "Apport de l'évaluation de l'ischémie de Membre supérieur Par oxymétrie transcutanée Dans la caractérisation de la Compression Vasculaire Chez Les Patients Suspects de Syndrome du défilé Thoraco-brachial", 'orgStudyIdInfo': {'id': '2022-161'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients Suspected of Having Thoracic Outlet Syndrome', 'description': 'Patients who came for the diagnosis of TOS', 'interventionNames': ['Diagnostic Test: Transcutaneous oximetry']}], 'interventions': [{'name': 'Transcutaneous oximetry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Comparison of the TcpO2 values recorded during dynamic maneuver with the estimated rate of compression of the subclavian and axillary vessels determined on dynamic angiography.', 'armGroupLabels': ['Patients Suspected of Having Thoracic Outlet Syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}