Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-03-15 @ 2:21 AM
Study NCT ID:
NCT02262494
Status:
TERMINATED
Last Update Posted:
2018-01-03
First Post:
2014-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'whyStopped': 'No recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-02', 'studyFirstSubmitDate': '2014-10-02', 'studyFirstSubmitQcDate': '2014-10-08', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnosis of deep vein thrombosis by portable ultrasound: yes/no', 'timeFrame': 'Day 0'}, {'measure': 'Diagnosis of deep vein thrombosis by doppler ultrasound: yes/no', 'timeFrame': 'Day 0'}], 'secondaryOutcomes': [{'measure': 'Diagnosis of deep vein thrombosis by classic ultrasound: yes/no', 'timeFrame': 'day 0'}, {'measure': 'Wells score', 'timeFrame': 'Day 0', 'description': 'score ranging from 0 to 6'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Deep Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'The main objective of our study is to determine the diagnostic performance of an ultra-portable ultrasound (V-Scan®) device for emergency compression ultrasound when used by experienced ermergency doctors searching for proximal deep vein thrombosis (DVT) in patients with no history of DVT. The gold standard is Doppler ultrasound of the lower limbs performed by a vascular exploration expert.', 'detailedDescription': 'The secondary objectives of this study are:\n\n* to compare the diagnostic performance of emergency compression ultrasonography performed with and ultra-portable device (V-Scan®) with that of emergency compression ultrasonography performed with a classic device\n* to compare the diagnostic performance of emergency compression ultrasonography between patients suspected of having DVT arriving through the emergency department versus similar patients sent in by their generalist\n* to compare the diagnostic performance of emergency compression ultrasonography among patients with suspected DVT according to pre clinical probability testing based on the Wells score (low, medium or high probability).\n\nCurrently, the use of ultra-portable ultrasound in this indication is not part of routine care, and this study is therefore considered interventional in nature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient must have given informed consent and signed consent\n* The patient must be a member or beneficiary of a health insurance plan\n* Patient consulting in the vascular exploration and medicine department for suspected first episode of deep vein thrombosis\n* Ambulatory patient: defined as any outpatient coming in for a consult directly from their place of residence or via the emergency department\n* Patient does not have a history of venous thromboembolism\n\nExclusion Criteria:\n\n* The patient is participating in another study\n* The patient is in an exclusion period determined by a previous study\n* The patient is an adult under any kind of guardianship\n* The patient refuses to sign the consent\n* It is not possible to correctly inform the patient\n* Patient has a history of venous thromboembolism'}, 'identificationModule': {'nctId': 'NCT02262494', 'acronym': 'EchoComp TVP', 'briefTitle': 'Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Location of Lower Extremity Deep Vein Thrombosis by Emergency Physicians Using Portable Compression Ultrasonography: a Diagnostic Study', 'orgStudyIdInfo': {'id': 'LOCAL/2013/XB-01'}, 'secondaryIdInfos': [{'id': '2014-A00510-47', 'type': 'OTHER', 'domain': 'RCB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Suspected first episode of DVT', 'description': 'The study population consists of patients presenting with suspected first episode of DVT at the Nîmes University Hospital.\n\nIntervention: portable venous compression ultrasonography Intervention: venous compress ultrasonography Intervention: Doppler ultrasound of the lower limbs', 'interventionNames': ['Procedure: portable venous compression ultrasonography', 'Procedure: venous compress ultrasonography', 'Procedure: Doppler ultrasound of the lower limbs']}], 'interventions': [{'name': 'portable venous compression ultrasonography', 'type': 'PROCEDURE', 'description': 'venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)', 'armGroupLabels': ['Suspected first episode of DVT']}, {'name': 'venous compress ultrasonography', 'type': 'PROCEDURE', 'description': 'venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)', 'armGroupLabels': ['Suspected first episode of DVT']}, {'name': 'Doppler ultrasound of the lower limbs', 'type': 'PROCEDURE', 'description': 'Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)', 'armGroupLabels': ['Suspected first episode of DVT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30029', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHRU de Nîmes - Hôpital Universitaire Carémeau', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}], 'overallOfficials': [{'name': 'Xavier Bobbia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}