Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT04720027
Status:
COMPLETED
Last Update Posted:
2022-08-15
First Post:
2021-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long Term Study of 3 Radiofrequency Devices
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-05-31', 'releaseDate': '2023-12-11'}], 'estimatedResultsFirstSubmitDate': '2023-12-11'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-12', 'studyFirstSubmitDate': '2021-01-18', 'studyFirstSubmitQcDate': '2021-01-18', 'lastUpdatePostDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical assessment of ablation of treated GSV segment', 'timeFrame': '5 years after treatment', 'description': 'Aanatomical assessment of total ablation of treated segment will be assessed:\n\nFailure will be defined as any segment of the treated trunk (\\> 2cm from the saphenofemoral junction) that is patent (compressible) and demonstrates reflux (\\>1 second) on duplex scanning.'}], 'secondaryOutcomes': [{'measure': 'Absence of recurrent varicose veins and or return of symptoms', 'timeFrame': '5 years after treatment', 'description': 'Assessments using disease specific (AVVQ) and generic (EQ5D) quality of life scores by means of self-completed questionnaires completed at a single consultation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Varicose Veins of Lower Limb']}, 'referencesModule': {'references': [{'pmid': '31351832', 'type': 'BACKGROUND', 'citation': 'Nyamekye IK, Dattani N, Hayes W, Harding D, Holloway S, Newman J. A Randomised Controlled Trial Comparing Three Different Radiofrequency Technologies: Short-Term Results of the 3-RF Trial. Eur J Vasc Endovasc Surg. 2019 Sep;58(3):401-408. doi: 10.1016/j.ejvs.2019.01.033. Epub 2019 Jul 24.'}, {'pmid': '36958479', 'type': 'DERIVED', 'citation': 'Nyamekye IK, Pullen BJ, Kelly N, Hayes W. Six Year Extension Study of Patients From a Randomised Clinical Trial Comparing Venefit, Radiofrequency Induced Thermal Therapy, and Endovenous Radiofrequency Ablation for Treatment of Incompetent Great Saphenous Veins. Eur J Vasc Endovasc Surg. 2023 Jul;66(1):94-101. doi: 10.1016/j.ejvs.2023.03.021. Epub 2023 Mar 21.'}]}, 'descriptionModule': {'briefSummary': "To establish which of the radiofrequency venous ablation modalities studied in the original 3RF study (Venefit (Closurefast), vs. Radiofrequency induced Thermal Therapy vs. Endovenous Radiofrequency) is most effective in relieving patients' symptoms and signs from varicose veins disease, and in maintaining absence of reflux in the treated vein segment (of the great saphenous vein (GSV)) 5 years following surgery.", 'detailedDescription': "Results of randomised trials and meta-analyses have shown that endovenous thermal ablation of the GSV using radiofrequency ablation or laser is associated with improved recovery compared with conventional surgery. Furthermore, radiofrequency ablation (using the Closurefast device) has been shown to cause less pain and require less analgesic intake than laser treatment. At the time the 3 RF study was conceived there were two other radiofrequency devices that were marketed to have theoretical advantages over the Closurefast technique. All three devices were in use in clinical practice (including at Worcestershire Royal Hospital) in 2013. The initial study focused on clinical results (up to 12 months) and anatomical results (up to 6 months) and remains the only clinical trial to date that has directly compared the outcomes of radiofrequency thermal ablation devices.\n\nThis second (long term) phase of the study aims to assess which of the radiofrequency venous ablation modalities studied in the original 3RF study (Venefit (Closurefast), vs. Radiofrequency induced Thermal Therapy vs. Endovenous Radiofrequency) is most effective in relieving patients' symptoms and signs from varicose veins disease, and in maintaining absence of reflux in the treated vein segment (of the great saphenous vein (GSV)) 5 years following surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '23 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The 180 patients who were originally recruited to and studied in the 3RF Study (clinicaltrials.gov identifier: NCT02441881)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients originally recruited to and studied in the 3RF Study (clinicaltrials.gov identifier: NCT02441881) who give informed consent to take part in this long term study\n\nExclusion Criteria:\n\n* Patients originally recruited to and studied in the 3RF Study (clinicaltrials.gov identifier: NCT02441881) who do not give informed consent to take part in this long term study'}, 'identificationModule': {'nctId': 'NCT04720027', 'acronym': '3RF-5Years', 'briefTitle': 'Long Term Study of 3 Radiofrequency Devices', 'organization': {'class': 'OTHER', 'fullName': 'Worcestershire Acute Hospitals NHS Trust'}, 'officialTitle': 'Long Term Outcomes of the Double Blind Randomised Controlled Trial of Radiofrequency Thermal Ablation Treatments of Great Saphenous Varicose Veins: Closurefast vs. RFITT vs. EVRF', 'orgStudyIdInfo': {'id': 'WorcestershireNHS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Closurefast', 'description': 'Patients who were randomised to and underwent radiofrequency ablation using the Closurefast device in the original 3RF Study', 'interventionNames': ['Diagnostic Test: Duplex imaging']}, {'label': 'Radiofrequency Induced Thermal Therapy (RFITT)', 'description': 'Patients who were randomised to and underwent radiofrequency ablation using the RFITT device in the original 3RF Study', 'interventionNames': ['Diagnostic Test: Duplex imaging']}, {'label': 'EndoVenous Radiofrequency (EVRF)', 'description': 'Patients who were randomised to and underwent radiofrequency ablation using the EVRF device in the original 3RF Study', 'interventionNames': ['Diagnostic Test: Duplex imaging']}], 'interventions': [{'name': 'Duplex imaging', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Completion of Quality Of Life Questionnaires'], 'description': 'Completion of AVVQ and EQ5D questionnairs', 'armGroupLabels': ['Closurefast', 'EndoVenous Radiofrequency (EVRF)', 'Radiofrequency Induced Thermal Therapy (RFITT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WR5 1DD', 'city': 'Worcester', 'state': 'Worcestershire', 'country': 'United Kingdom', 'facility': 'Worcestershire Acute Hospitals NHS Trust', 'geoPoint': {'lat': 52.18935, 'lon': -2.22001}}], 'overallOfficials': [{'name': 'Isaac Nyamekye, FRCS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Worcestershire Acute Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not plan to share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Worcestershire Acute Hospitals NHS Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-12-11', 'type': 'RELEASE'}, {'date': '2024-05-31', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Worcestershire Acute Hospitals NHS Trust'}}}}