Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-30 @ 1:13 AM
Study NCT ID:
NCT01103258
Status:
COMPLETED
Last Update Posted:
2010-04-14
First Post:
2010-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FOAM-study, Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 460}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-12', 'studyFirstSubmitDate': '2010-04-06', 'studyFirstSubmitQcDate': '2010-04-12', 'lastUpdatePostDateStruct': {'date': '2010-04-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cumulative probability of recurrent varicose vein within 24 months after treatment', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'quality of life (as measured by EuroQol-5D)', 'timeFrame': '24 months'}, {'measure': 'patient preferences (as measured by conjoint analysis)', 'timeFrame': '24 months'}, {'measure': 'direct Health care costs', 'timeFrame': '24 months', 'description': 'materials, operation costs, personnel costs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Incompetence of the great saphenous vein.'], 'conditions': ['Varicose Vein Disease']}, 'referencesModule': {'references': [{'pmid': '22627969', 'type': 'DERIVED', 'citation': 'Shadid N, Ceulen R, Nelemans P, Dirksen C, Veraart J, Schurink GW, van Neer P, vd Kley J, de Haan E, Sommer A. Randomized clinical trial of ultrasound-guided foam sclerotherapy versus surgery for the incompetent great saphenous vein. Br J Surg. 2012 Aug;99(8):1062-70. doi: 10.1002/bjs.8781. Epub 2012 May 25.'}]}, 'descriptionModule': {'briefSummary': 'Varicose vein disease is a common health problem, which causes much discomfort to patients.\n\nNowadays treatment modalities for greater saphenous veins include surgery and duplex guided foam sclerotherapy. These are two equally accepted and applied treatments for the same patient population.\n\nChoice of treatment often depends on the referral preference of the General Practitioner. Until now data are missing which treatment is more cost effective. The current proposal aims at comparing the effects, costs and patient preferences between duplex guided foam sclerotherapy and surgery in the treatment of greater varicose veins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* incompetence of great saphenous vein for minimal 20 cm\n* life expectancy at least 3 years\n* open and competent deep venous system\n* willing to undergo both treatments\n\nExclusion Criteria:\n\n* active ulcer\n* signs of deep venous thrombosis with duplex\n* incompetence of the deep venous system'}, 'identificationModule': {'nctId': 'NCT01103258', 'briefTitle': 'FOAM-study, Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'FOAM-study Cost Minimization Study Comparing Surgery Versus Duplex Guided Foam Sclerotherapy of Varicose Veins: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'MEC 05-2-014'}, 'secondaryIdInfos': [{'id': 'ZON MW 4636', 'type': 'OTHER_GRANT', 'domain': 'ZON MW'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'high ligation and stripping', 'description': 'surgery consisting of high ligation in combination with long saphenous stripping', 'interventionNames': ['Procedure: high ligation and stripping (surgery)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'duplex guided foam sclerotherapy', 'description': 'duplex guided foam sclerotherapy', 'interventionNames': ['Procedure: FOAM']}], 'interventions': [{'name': 'high ligation and stripping (surgery)', 'type': 'PROCEDURE', 'description': 'surgery consisting of high ligation in combination with long saphenous stripping', 'armGroupLabels': ['high ligation and stripping']}, {'name': 'FOAM', 'type': 'PROCEDURE', 'description': 'duplex guided foam sclerotherapy', 'armGroupLabels': ['duplex guided foam sclerotherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht UMC', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'A Sommer, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Maastricht UMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'ZonMw: The Netherlands Organisation for Health Research and Development', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr A Sommer', 'oldOrganization': 'Maastricht UMC'}}}}