Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-03-07 @ 7:22 PM
Study NCT ID:
NCT02046967
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2014-01-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014648', 'term': 'Varicose Veins'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-27', 'studyFirstSubmitDate': '2014-01-23', 'studyFirstSubmitQcDate': '2014-01-27', 'lastUpdatePostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Obliteration of varicose vein and/ or absence of reflux (>0.5 sec. of retrograde flow over >10cm) along the treated segment of the great saphenous vein (GSV) at 12 and 52 weeks.', 'timeFrame': '52 weeks'}], 'secondaryOutcomes': [{'measure': 'Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.', 'timeFrame': '12 weeks'}, {'measure': 'Minor complications: ecchymosis, pain and hyperpigmentation.', 'timeFrame': '12 weeks'}, {'measure': 'Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ).', 'timeFrame': '12 weeks'}, {'measure': 'Treatment satisfaction', 'timeFrame': '2 weeks'}, {'measure': 'Pain score', 'timeFrame': '2 weeks'}, {'measure': 'Venous Clinical Severity Score (VCSS)', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['endovenous laser ablation', 'endovenous steam ablation', 'great saphenous veins', 'quality of life'], 'conditions': ['Varicose Veins', 'Varicose Veins of Leg With Long Saphenous Vein Distribution']}, 'referencesModule': {'references': [{'pmid': '24981585', 'type': 'DERIVED', 'citation': 'van den Bos RR, Malskat WS, De Maeseneer MG, de Roos KP, Groeneweg DA, Kockaert MA, Neumann HA, Nijsten T. Randomized clinical trial of endovenous laser ablation versus steam ablation (LAST trial) for great saphenous varicose veins. Br J Surg. 2014 Aug;101(9):1077-83. doi: 10.1002/bjs.9580. Epub 2014 Jun 30.'}]}, 'descriptionModule': {'briefSummary': 'Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a very high success rate. It works by heating and thereby obliterating the vein. Steam ablation is a new therapy that also works by heating and thereby obliterating the vein. The hypothesis of this study is that steam ablation is as effective as laser ablation, but that it results in better secondary outcomes (e.g., lower pain scores).', 'detailedDescription': 'The study is a randomized clinical trial comparing two different therapies for endovenous ablation of great saphenous veins. The aim of the study is to test whether the anatomical success rate of Steam Ablation is not inferior to that of Endovenous laser ablation (EVLA) in treatment of great saphenous vein insufficiency and compare the treatment safety, patient reported outcomes and cost-effectiveness analyses between EVLA and Steam Ablation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old\n* Insufficiency of the GSV measured with ultrasound imaging, reflux \\> 0.5 s, and diameter of vein \\> 0.5 cm\n* Symptoms of chronic venous insufficiency\n* No prior treatment of the insufficient GSV\n* Informed consent\n\nExclusion Criteria:\n\n* Acute deep or superficial vein thrombosis\n* Agenesis of deep vein system\n* Vascular malformation or syndrome\n* Post-thrombotic syndrome, occlusive type\n* Pregnancy\n* Immobility\n* Allergy to lidocaine\n* Arterial insufficiency'}, 'identificationModule': {'nctId': 'NCT02046967', 'acronym': 'LAST', 'briefTitle': 'Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Comparative Randomized Clinical Trial of Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins', 'orgStudyIdInfo': {'id': 'ErasmusMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Endovenous laser ablation', 'description': 'Endovenous laser ablation with 940 nm bare fiber.', 'interventionNames': ['Procedure: Endovenous laser ablation with 940 nm bare fiber']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endovenous steam ablation', 'description': 'Endovenous steam ablation with steam vein sclerosis system.', 'interventionNames': ['Procedure: Endovenous steam ablation with steam vein sclerosis system.']}], 'interventions': [{'name': 'Endovenous laser ablation with 940 nm bare fiber', 'type': 'PROCEDURE', 'otherNames': ['EVLT', 'EVLA'], 'description': 'Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.', 'armGroupLabels': ['Endovenous laser ablation']}, {'name': 'Endovenous steam ablation with steam vein sclerosis system.', 'type': 'PROCEDURE', 'otherNames': ['SVS', 'EVSA'], 'description': 'Endovenous steam ablation with steam vein sclerosis.', 'armGroupLabels': ['Endovenous steam ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015 CA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'overallOfficials': [{'name': 'Renate R van den Bos, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Erasmus Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'RR van den Bos', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}