Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
Study NCT ID:
NCT05663359
Status:
RECRUITING
Last Update Posted:
2025-02-12
First Post:
2022-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on Treatment of Varicose Veins by Endovenous Laser (1940 nm vs 1470 nm)
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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 280}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2031-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2022-12-15', 'studyFirstSubmitQcDate': '2022-12-15', 'lastUpdatePostDateStruct': {'date': '2025-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical success', 'timeFrame': 'At 5 years', 'description': 'Closure of the target vein'}], 'secondaryOutcomes': [{'measure': 'VAS Pain', 'timeFrame': 'Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5', 'description': 'Visual Analogue Scale (0-100 mm); higher is worse'}, {'measure': 'Adverse Events', 'timeFrame': 'Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5', 'description': 'Adverse events related to endovenous treatment'}, {'measure': 'Venous Clinical Severity', 'timeFrame': 'Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5', 'description': 'Venous Clinical Severity Score (VCSS) ; score between 0 to 30; higher is worse'}, {'measure': 'Symptoms', 'timeFrame': 'Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5', 'description': 'VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire'}, {'measure': 'Patient quality of life (1)', 'timeFrame': 'Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5', 'description': 'VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - quality of life ) questionnaire'}, {'measure': 'Patient quality of life (2)', 'timeFrame': 'Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5', 'description': 'EuroQol-5 Dimension (EQ5D) Quality of life survey'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endovenous laser ablation (EVLA)'], 'conditions': ['Varicose Veins']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare efficacy of two wavelength for EndoVenous Laser Ablation (EVLA) in treatment of varicose veins of the lower limbs.\n\nThe main questions it aims to answers are :\n\n1. Is the increase of wavelength form 1470 nm to 1940 nm affect the efficacy of varicose veins treatment ?\n2. Is the increase of wavelength reduce complication or pain ? Participants are patients with varicose veins of lower limbs and candidate for endovenous laser ablation.\n\nAfter laser ablation patients will be followed during 5 years for clinical evaluation, recording potential treatment complications and quality of life evaluation.\n\nResearchers will compare strategy 1(EVLA with an endovenous laser at 1940 nm) vs strategy 2 (EVLA with an endovenous laser at 1470 nm) in varicose veins treatment to see if efficacy of treatment is not reduce, and to see if complications of EVLA treatment can be reduced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary insufficiency of the great saphenous vein (GSV) and/or small saphenous vein (SSV)\n* Patient candidate for endothermic treatment of the lower limbs\n* CEAP: C2 - C6\n* Patient with a target vein diameter (GSV and/or SSV) \\>= 3 mm throughout the target vein segment\n* Patient affiliated or beneficiary of a social security scheme\n* Patient having signed the informed consent\n\nExclusion Criteria:\n\n* Patient with a current serious pathology and/or a life expectancy of less than 5 years\n* Patient who has had a deep or superficial vein thrombosis in the previous 6 months\n* Obliterating arteriopathy of the lower limb concerned, with an IPS \\< 0.8 or \\> 1.3\n* Patient with post-thrombotic obstructive syndrome at the popliteal and/or femoral and/or iliac stage on the ipsilateral lower limb\n* Patient with primary or post-thrombotic axial deep venous reflux on the ipsilateral lower limb\n* Suspicion of non-post-thrombotic iliac compression on echo-doppler\n* Contraindication to the planned treatment technique\n* Patient whose geographical distance is not compatible with the follow-up of the study\n* Pregnant or breastfeeding women\n* Patient linguistically or psychologically unable to understand the information given, to give informed consent or to answer the study questionnaires.\n* Protected patients: Adults under guardianship, or other legal protection; Hospitalized without consent.'}, 'identificationModule': {'nctId': 'NCT05663359', 'acronym': 'NEWWAVE', 'briefTitle': 'Study on Treatment of Varicose Veins by Endovenous Laser (1940 nm vs 1470 nm)', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Pasteur'}, 'officialTitle': 'Randomized Comparative Study With Two Wavelengths 1470 nm and 1940 nm for the Treatment of Varicose Veins of the Lower Limbs by Endovenous Laser.', 'orgStudyIdInfo': {'id': '2022-A01722-41'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1940 nm', 'description': 'Endovenous laser at 1940 nm', 'interventionNames': ['Procedure: EVLA 1940 nm']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1470 nm', 'description': 'Endovenous laser at 1470 nm', 'interventionNames': ['Procedure: EVLA 1470 nm']}], 'interventions': [{'name': 'EVLA 1940 nm', 'type': 'PROCEDURE', 'description': 'Treatment of varicose veins by endothermic ablation with an endovenous laser at 1940 nm', 'armGroupLabels': ['1940 nm']}, {'name': 'EVLA 1470 nm', 'type': 'PROCEDURE', 'description': 'Treatment of varicose veins by endothermic ablation with an endovenous laser at 1470 nm', 'armGroupLabels': ['1470 nm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nicolas NEAUME, MD', 'role': 'CONTACT', 'email': 'nneaume@clinique-pasteur.com', 'phone': '+33 5 61 16 13 01'}, {'name': 'Nicolas NEAUME, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Laurence Allouche, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Fannie Forgues, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Yacine Oudrhiri, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinique Pasteur', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Nicolas NEAUME, MD', 'role': 'CONTACT', 'email': 'nneaume@clinique-pasteur.com', 'phone': '+33 5 61 16 13 03'}], 'overallOfficials': [{'name': 'Nicolas NEAUME, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Pasteur'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Pasteur', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, MD', 'investigatorFullName': 'Nicolas NEAUME', 'investigatorAffiliation': 'Clinique Pasteur'}}}}