Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-30 @ 11:47 PM
Study NCT ID:
NCT05468450
Status:
COMPLETED
Last Update Posted:
2022-07-21
First Post:
2022-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053685', 'term': 'Laser Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Blinding of participants and investigators is not possible because of the obvious differences between the two treatments (a single mid-calf injection versus multiple injections for tumescent anaesthesia/laser precautions etc…).\n\nA blind third-party check was carried out, only at 3 years, and those assessors were completely independent of the study and blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating small saphenous veins (SSV) insufficiency'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-19', 'studyFirstSubmitDate': '2022-07-13', 'studyFirstSubmitQcDate': '2022-07-19', 'lastUpdatePostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of reflux in the treated SSV segment', 'timeFrame': '3Assessed at years', 'description': 'closed veins or patent veins with no reflux (\\>0.5sec)'}], 'secondaryOutcomes': [{'measure': 'Treatment time', 'timeFrame': 'Assessed on day of treatment', 'description': 'Time (in minutes) spent in undertaking each treatment'}, {'measure': 'Procedure related complications', 'timeFrame': 'Assessed through study completion, an average of 3 years', 'description': 'Any related complications arising from the procedure'}, {'measure': 'Periprocedural pain score', 'timeFrame': 'up to four weeks', 'description': 'assessed on a visual analogue score (zero = no pain, 100 = maximum pain)'}, {'measure': 'Presence of visible varices', 'timeFrame': 'Through study completion, average of 3 years', 'description': 'Reported recurrence of varicose veins'}, {'measure': 'Venous symptoms questionnaire', 'timeFrame': 'Through study completion, average of 3 years', 'description': 'Validated questionnaire scores'}, {'measure': 'Revised Venous Clinical Severity Score -rVCSS', 'timeFrame': 'Through study completion, average of 3 years', 'description': 'Validated questionnaire scores'}, {'measure': 'Quality of Life questionnaire (CIVIQ)', 'timeFrame': 'Through study completion, average of 3 years', 'description': 'Validated questionnaire scores'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['small saphenous veins', 'varicose veins', 'ultrasound guided foam sclerotherapy', 'endovenous laser ablation'], 'conditions': ['Varicose Veins of Lower Limb']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': "9) Hamel-Desnos C., Josnin M., Allaert F.-A. Etude contrôlée randomisée de l'efficacité du laser endoveineux (1470 nm) versus échosclérothérapie à la mousse dans le traitement de l'insuffisance de la petite veine saphène. Phlébologie 2019 (72): 8-18"}, {'pmid': '36470312', 'type': 'DERIVED', 'citation': 'Hamel-Desnos C, Nyamekye I, Chauzat B, Gracia S, Josnin M, Abbadie F. FOVELASS: A Randomised Trial of Endovenous Laser Ablation Versus Polidocanol Foam for Small Saphenous Vein Incompetence. Eur J Vasc Endovasc Surg. 2023 Mar;65(3):415-423. doi: 10.1016/j.ejvs.2022.11.021. Epub 2022 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'FOVELASS is a multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating SSV insufficiency, conducted by the French Society of Phlebology.', 'detailedDescription': 'Saphenous vein insufficiency is a common finding in varicose veins cases. International guidelines currently recommend endovenous thermal ablation using laser (EVLA) or radiofrequency as first line treatment for truncal Great Saphenous Vein (GSV) incompetence in preference to Ultrasound Guided Foam Sclerotherapy (UGFS) (1,2). This GSV-based recommendation has tended to be used for treating Small Saphenous Vein (SSV) incompetence.\n\nTo date, no RCTs have directly compared UGFS and EVLA for SSV treatment. The French Society of Phlebology (SFP) decided to compare these two most utilised endovenous treatments in France in a controlled study called the FOam VErsus LAser in the SSv (FOVELASS) study, involving 13 investigators in 11 vascular medical centres.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic varicose veins (CEAP C2s-C6)\n* underlying isolated SSV incompetence (SSV reflux time\\>0.5sec on duplex ultrasound (DUS))\n* reflux involving at least 15 cm of proximal SSV\n* minimal SSV diameter of 4 mm at mid-calf (luminal diameter in standing position)\n\nExclusion Criteria:\n\n* SSV treatment in the preceding 3 months\n* post-thrombotic disease\n* deep or superficial vein thrombosis of less than 3 months duration\n* coexistent ipsilateral GSV insufficiency\n* morbid obesity (BMI\\>40)\n* presence of significant arterial disease (ABPI\\<0.5)'}, 'identificationModule': {'nctId': 'NCT05468450', 'acronym': 'FOVELASS', 'briefTitle': 'RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency', 'organization': {'class': 'OTHER', 'fullName': 'Societe Francaise de Phlebologie'}, 'officialTitle': 'Three-year Outcomes of a RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency (FOVELASS Study, by the French Society of Phlebology)', 'orgStudyIdInfo': {'id': '2014-A01943-44'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound-guided-foam sclerotherapy (UGFS)', 'description': 'Injection of Polidocanol foam into SSV', 'interventionNames': ['Drug: Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endovenous Laser Ablation (EVLA)', 'description': 'Ablation of SSV using laser energy', 'interventionNames': ['Device: Endovenous Laser Ablation (EVLA)']}], 'interventions': [{'name': 'Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant', 'type': 'DRUG', 'otherNames': ['Foam sclerotherapy'], 'description': 'Direct injection Foam sclerotherapy', 'armGroupLabels': ['Ultrasound-guided-foam sclerotherapy (UGFS)']}, {'name': 'Endovenous Laser Ablation (EVLA)', 'type': 'DEVICE', 'otherNames': ['Laser therapy'], 'description': 'EVLA using a 1470nm generator and 600-micron radial fibres (Biolitec® Biomedical Technology, Jena, Germany), under tumescent local anaesthesia (TLA)', 'armGroupLabels': ['Endovenous Laser Ablation (EVLA)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Claudine Hamel-Desnos', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut des Varices- GHPJS Groupe Hospitalier'}, {'name': 'Matthieu Josnin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Société Française de Phlébologie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Randomised is provided by the independent statistics centre (Cenbiotech; Dijon-France), who also analysed IPD. Investigators cannot access other centres' data."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Societe Francaise de Phlebologie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}