Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2026-01-26 @ 7:19 AM
Study NCT ID:
NCT00509392
Status:
COMPLETED
Last Update Posted:
2017-07-12
First Post:
2007-07-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.
Sponsor:
Organization:
Raw JSON
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publication, communication or scientific presentation prior to said dissemination.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 Month', 'description': 'Number of subjects at risk = Number of subjects with adverse event information', 'eventGroups': [{'id': 'EG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)', 'otherNumAtRisk': 46, 'otherNumAffected': 2, 'seriousNumAtRisk': 46, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Endovenous Laser (EVL) Ablation', 'description': 'Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)', 'otherNumAtRisk': 41, 'otherNumAffected': 9, 'seriousNumAtRisk': 41, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hyperpigmentation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 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Above or below tx segment', 'unitOfMeasure': 'limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Data available at 1- month follow-up visit'}, {'type': 'PRIMARY', 'title': 'Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'limbs', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)'}, {'id': 'OG001', 'title': 'Endovenous Laser (EVL) Ablation', 'description': 'Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)'}], 'classes': [{'title': 'Hyperpigmentation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Phlebitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Paresthesia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Infection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Thrombus Extention (TE)/Deep Vein Thrombosis (DVT)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': '1 month', 'description': 'Sequelae at any follow-up', 'unitOfMeasure': 'limbs', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Data up to one month follow up visit'}, {'type': 'SECONDARY', 'title': 'VCSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'limbs', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)'}, {'id': 'OG001', 'title': 'Endovenous Laser (EVL) Ablation', 'description': 'Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0009', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '48 Hours', 'description': 'Venous Clinical Severity Score (0-30 total overall score):\n\n0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Data at 48 hours for follow up visit'}, {'type': 'SECONDARY', 'title': 'VCSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'limbs', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)'}, {'id': 'OG001', 'title': 'Endovenous Laser (EVL) Ablation', 'description': 'Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.2', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '2.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 Week', 'description': 'Venous Clinical Severity Score (0-30 total overall score):\n\n0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Data at 1-week follow up visit'}, {'type': 'SECONDARY', 'title': 'VCSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'limbs', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)'}, {'id': 'OG001', 'title': 'Endovenous Laser (EVL) Ablation', 'description': 'Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0035', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '2 Weeks', 'description': 'Venous Clinical Severity Score (0-30 total overall score):\n\n0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Data at 2 week follow up visit'}, {'type': 'SECONDARY', 'title': 'VCSS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'limbs', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)'}, {'id': 'OG001', 'title': 'Endovenous Laser (EVL) Ablation', 'description': 'Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.7', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2825', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 Month', 'description': 'Venous Clinical Severity Score (0-30 total overall score):\n\n0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Data at 1- month follow up visit'}, {'type': 'SECONDARY', 'title': 'Change in CIVIQ QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'limbs', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)'}, {'id': 'OG001', 'title': 'Endovenous Laser (EVL) Ablation', 'description': 'Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.5', 'spread': '14.6', 'groupId': 'OG000'}, {'value': '-7.1', 'spread': '19.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0854', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '48 Hours', 'description': 'Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).\n\nGlobal index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.\n\nChange from Baseline', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Data at 48 hrs follow up visit'}, {'type': 'SECONDARY', 'title': 'Change in CIVIQ QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'limbs', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)'}, {'id': 'OG001', 'title': 'Endovenous Laser (EVL) Ablation', 'description': 'Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.1', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '-9.4', 'spread': '13.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0044', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 Week', 'description': 'Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).\n\nGlobal index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.\n\nChange from Baseline', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Data at one week follow up visit'}, {'type': 'SECONDARY', 'title': 'Change in CIVIQ QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'limbs', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)'}, {'id': 'OG001', 'title': 'Endovenous Laser (EVL) Ablation', 'description': 'Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)'}], 'classes': [{'categories': [{'measurements': [{'value': '-19.9', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '-12.4', 'spread': '17.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0457', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '2 Week', 'description': 'Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL) (Min 20- Max 100).\n\nGlobal index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.\n\nChange from Baseline', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Data at 2-week follow up visit'}, {'type': 'SECONDARY', 'title': 'Change in CIVIQ QOL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}, {'units': 'limbs', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)'}, {'id': 'OG001', 'title': 'Endovenous Laser (EVL) Ablation', 'description': 'Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.8', 'spread': '15.4', 'groupId': 'OG000'}, {'value': '-17.5', 'spread': '15.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9463', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': '1 Month', 'description': 'Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).\n\nGlobal index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.\n\nChange from Baseline', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'limbs', 'denomUnitsSelected': 'limbs', 'populationDescription': 'Data at 1 month follow-up visit'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)'}, {'id': 'FG001', 'title': 'Endovenous Laser (EVL) Ablation', 'description': 'Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)'}, {'id': 'FG002', 'title': 'RF / EVLA', 'description': 'Bilateral treatment where one limb is treated with RFA and the contralateral limb is treated with EVL'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '42', 'numSubjects': '32'}, {'groupId': 'FG001', 'numUnits': '37', 'numSubjects': '33'}, {'groupId': 'FG002', 'numUnits': '8', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '42', 'numSubjects': '32'}, {'groupId': 'FG001', 'numUnits': '37', 'numSubjects': '33'}, {'groupId': 'FG002', 'numUnits': '8', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG001', 'numUnits': '0', 'numSubjects': '0'}, {'groupId': 'FG002', 'numUnits': '0', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'limbs', 'recruitmentDetails': 'Recruitment from March - December 2007. Medical offices/clinics and university hospital.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'units': 'limbs', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'Radiofrequency (RF) thermal ablation using the ClosureFAST (CLF) RF Catheter (VNUS Medical Technologies, San Jose, CA)'}, {'id': 'BG001', 'title': 'Endovenous Laser (EVL) Ablation', 'description': 'Endovenous Laser (EVL) ablation with a 980-nm laser (Biolitec, East Longmeadow, MA)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'limbs', 'denomUnitsSelected': 'limbs'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.6', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '52.4', 'spread': '15.3', 'groupId': 'BG001'}, {'value': '52.37', 'spread': '15.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'unitOfMeasure': 'limbs', 'denomUnitsSelected': 'limbs'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'limbs', 'denomUnitsSelected': 'limbs'}, {'title': 'VCSS', 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '3.1', 'groupId': 'BG000'}, {'value': '4.9', 'spread': '2.8', 'groupId': 'BG001'}, {'value': '4.8', 'spread': '3.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Venous Clinical Severity Score (0-30 total overall score):\n\n0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'limbs'}, {'title': 'CEAP', 'classes': [{'title': 'CEAP Class 2', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Not CEAP Class 2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Clinical/Etiology/Anatomy/Pathophysiology Score\n\nCEAP Class 2: Clinical classification for individuals with varicose veins', 'unitOfMeasure': 'limbs', 'denomUnitsSelected': 'limbs'}, {'title': 'CIVIQ', 'classes': [{'categories': [{'measurements': [{'value': '40.6', 'spread': '17.2', 'groupId': 'BG000'}, {'value': '40', 'spread': '14.5', 'groupId': 'BG001'}, {'value': '40.3', 'spread': '15.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life (QOL). (Min 20- Max 100).\n\nGlobal index and an outline of 4 quality-of-life dimensions-"pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.', 'unitOfMeasure': 'Score on a questionnaire', 'dispersionType': 'STANDARD_DEVIATION', 'denomUnitsSelected': 'limbs'}], 'typeUnitsAnalyzed': 'limbs', 'populationDescription': '69 subjects were enrolled and 87 limbs were treated. There were 4 enrolled subjects that had bilateral treatment where one limb was treated with RF and the other limb was treated with EVL. To account for this, 2 subjects were added to the total number of baseline RF participant group and 2 were added to the baseline EVL participant group.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-13', 'studyFirstSubmitDate': '2007-07-27', 'resultsFirstSubmitDate': '2012-03-22', 'studyFirstSubmitQcDate': '2007-07-27', 'lastUpdatePostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-13', 'studyFirstPostDateStruct': {'date': '2007-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain', 'timeFrame': '48 Hour', 'description': 'Pain 0-10 scale (10 most severe)'}, {'measure': 'Pain', 'timeFrame': '1 Week', 'description': 'Pain 0-10 scale (10 most severe)'}, {'measure': 'Pain', 'timeFrame': '2 Weeks', 'description': 'Pain 0-10 scale (10 most severe)'}, {'measure': 'Pain', 'timeFrame': '1 Month', 'description': 'Pain 0-10 scale (10 most severe)'}, {'measure': 'Tenderness', 'timeFrame': '48 Hour', 'description': 'Tenderness 0-10 scale (10 most severe)'}, {'measure': 'Tenderness', 'timeFrame': '1 Week', 'description': 'Tenderness 0-10 scale (10 most severe)'}, {'measure': 'Tenderness', 'timeFrame': '2 Weeks', 'description': 'Tenderness 0-10 scale (10 most severe)'}, {'measure': 'Tenderness', 'timeFrame': '1 Month', 'description': 'Tenderness 0-10 scale (10 most severe)'}, {'measure': 'Ecchymosis', 'timeFrame': '48 Hours post treatment (no baseline)', 'description': '0-5 scale (5 most severe) 0: None\n\n1. \\<25%\n2. 25-50%\n3. 50-75%\n4. 75-100%\n5. Above or below treated (tx) segment'}, {'measure': 'Ecchymosis', 'timeFrame': '1 Week post treatment (no baseline)', 'description': '0-5 scale (5 most severe) 0: None\n\n1. \\<25%\n2. 25-50%\n3. 50-75%\n4. 75-100%\n5. Above or below tx segment'}, {'measure': 'Ecchymosis', 'timeFrame': '2 Weeks post treatment (no baseline)', 'description': '0-5 scale (5 most severe) 0: None\n\n1. \\<25%\n2. 25-50%\n3. 50-75%\n4. 75-100%\n5. Above or below tx segment'}, {'measure': 'Ecchymosis', 'timeFrame': '1 Month post treatment (no baseline)', 'description': '0-5 scale (5 most severe) 0: None\n\n1. \\<25%\n2. 25-50%\n3. 50-75%\n4. 75-100%\n5. Above or below tx segment'}, {'measure': 'Complications', 'timeFrame': '1 month', 'description': 'Sequelae at any follow-up'}], 'secondaryOutcomes': [{'measure': 'VCSS', 'timeFrame': '48 Hours', 'description': 'Venous Clinical Severity Score (0-30 total overall score):\n\n0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease'}, {'measure': 'VCSS', 'timeFrame': '1 Week', 'description': 'Venous Clinical Severity Score (0-30 total overall score):\n\n0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease'}, {'measure': 'VCSS', 'timeFrame': '2 Weeks', 'description': 'Venous Clinical Severity Score (0-30 total overall score):\n\n0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease'}, {'measure': 'VCSS', 'timeFrame': '1 Month', 'description': 'Venous Clinical Severity Score (0-30 total overall score):\n\n0(minimum)- No evidence of venous disease 30(maximum)- Severe venous disease'}, {'measure': 'Change in CIVIQ QOL', 'timeFrame': '48 Hours', 'description': 'Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).\n\nGlobal index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.\n\nChange from Baseline'}, {'measure': 'Change in CIVIQ QOL', 'timeFrame': '1 Week', 'description': 'Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).\n\nGlobal index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.\n\nChange from Baseline'}, {'measure': 'Change in CIVIQ QOL', 'timeFrame': '2 Week', 'description': 'Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL) (Min 20- Max 100).\n\nGlobal index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.\n\nChange from Baseline'}, {'measure': 'Change in CIVIQ QOL', 'timeFrame': '1 Month', 'description': 'Chronic Venous Insufficiency Questionnaire(CIVIQ) for Quality of Life(QOL). (Min 20- Max 100).\n\nGlobal index and an outline of 4 quality-of-life dimensions: "pain" (4 items), "physical" (4 items), "psychological" (9 items), and "social" (3 items). A low global (total) score corresponds to greater patient comfort.\n\nChange from Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Varicose veins, venous reflux, GSV disease'], 'conditions': ['Venous Reflux']}, 'referencesModule': {'references': [{'pmid': '19395275', 'type': 'RESULT', 'citation': 'Almeida JI, Kaufman J, Gockeritz O, Chopra P, Evans MT, Hoheim DF, Makhoul RG, Richards T, Wenzel C, Raines JK. Radiofrequency endovenous ClosureFAST versus laser ablation for the treatment of great saphenous reflux: a multicenter, single-blinded, randomized study (RECOVERY study). J Vasc Interv Radiol. 2009 Jun;20(6):752-9. doi: 10.1016/j.jvir.2009.03.008. Epub 2009 Apr 22.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this post-market study is to compare the post-procedure recovery between two types of minimally invasive catheter treatments for venous disease in the Great Saphenous Vein.', 'detailedDescription': 'Comparison of the post-procedure recovery of radiofrequency (RFA) treatment vs. laser treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All subjects must provide written informed consent.\n* Must be a candidate for either treatment with Radiofrequency Ablation (RFA) or endovenous laser.\n\nExclusion Criteria:\n\n* Subjects who require additional treatments in either leg within 30 days before or after the study procedure.\n* Subjects who are participating in another investigational study.'}, 'identificationModule': {'nctId': 'NCT00509392', 'acronym': 'RECOVERY', 'briefTitle': 'ClosureFAST vs. Laser Ablation for the Treatment of GSV Disease: A Multicenter, Single-Blinded, Randomized Study.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Endovascular'}, 'officialTitle': 'Radiofrequency Endovenous ClosureFAST vs. Laser Ablation for the Treatment of Great Saphenous Reflux: A Multicenter, Single-Blinded, Randomized Study (RECOVERY)', 'orgStudyIdInfo': {'id': 'CVL-06-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Seg. RF Ablation & ClosureFAST catheter', 'description': 'Seg. RF Ablation \\& ClosureFAST catheter', 'interventionNames': ['Device: Seg. RF Ablation & ClosureFAST catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Endovenous Laser', 'description': 'Treatment invention of venous disease with an Endovenous Laser.', 'interventionNames': ['Device: Endovenous Laser']}], 'interventions': [{'name': 'Seg. RF Ablation & ClosureFAST catheter', 'type': 'DEVICE', 'otherNames': ['VNUS'], 'description': 'Seg. RF Ablation \\& ClosureFAST catheter', 'armGroupLabels': ['Seg. RF Ablation & ClosureFAST catheter']}, {'name': 'Endovenous Laser', 'type': 'DEVICE', 'otherNames': ['Commercially approved laser catheter systems.'], 'description': 'laser catheter', 'armGroupLabels': ['Endovenous Laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'overallOfficials': [{'name': 'Lian Cunningham, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'VNUS Medical Technologies, A Covidien Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Endovascular', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'VNUS Medical Technologies, A Covidien Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}