Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 11:19 AM
Study NCT ID:
NCT00182208
Status:
COMPLETED
Last Update Posted:
2008-07-22
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011186', 'term': 'Postphlebitic Syndrome'}, {'id': 'D054070', 'term': 'Postthrombotic Syndrome'}], 'ancestors': [{'id': 'D010689', 'term': 'Phlebitis'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014689', 'term': 'Venous Insufficiency'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2005-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-21', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Success measured with the Global Rating Instrument'}], 'secondaryOutcomes': [{'measure': 'PTS-CCS questionnaire'}, {'measure': 'Villalta Scale'}, {'measure': 'Veines Quality of Life Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['PTS', 'Post phlebitic Syndrome', 'Activities of Daily Living', 'Quality of Life'], 'conditions': ['Postphlebitic Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether daily use of a lower limb venous-return assist device, "Venowave\', improves leg symptoms, ability to perform activities of daily living, and quality of life in subjects with severe PTS.', 'detailedDescription': "Eligible consenting patients will be randomly allocated to receive either the veno-device (active or placebo for 8 weeks and crossed over for a further 8 weeks (active or placebo) following a 4 week 'wash out' period.( A randomized controlled 'crossover' study}"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Past History of objectively documented deep vein thrombosis\n* Daily leg swelling with discomfort (i.e. report at least one of the following symptoms: heavy legs, aching legs and/or throbbing) for a minimum of 6 months\n* Over 18 years of age (and of either gender).\n* Villalta score of greater than 14(i.e.severe post phlebitic syndrome)\n\nExclusion Criteria:\n\n* Episode of objectively documented deep vein thrombosis occurred less than 6 months before recruitment\n* Subjects report that their symptoms have been unstable (worsening, improving or variable over the previous month).\n* Active venous ulceration\n* Baseline leg circumference greater than 50 cm (cuff will not fit subject)\n* Symptomatic peripheral arterial disease Peripheral neuropathy'}, 'identificationModule': {'nctId': 'NCT00182208', 'briefTitle': 'Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CTMG-2005-VENOPTS'}, 'secondaryIdInfos': [{'id': 'Health Canada No.:64844'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Veno-device (Venowave)', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8V 1C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Henderson Research Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Sir Mortimer B. Davis Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': "Martin O'Donnell, MB MRCPI", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hamilton Health Sciences Corporation'}, {'name': 'Susan R Kahn, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medicine McGill University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Health Canada', 'class': 'OTHER_GOV'}]}}}