Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 2:06 AM
Study NCT ID:
NCT01197833
Status:
COMPLETED
Last Update Posted:
2021-04-21
First Post:
2010-09-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014648', 'term': 'Varicose Veins'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.wright@btgplc.com', 'phone': '610-278-1660', 'title': 'David Wright MB FRCS', 'organization': 'BTG International Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Endovenous Ablation, Vehicle Placebo', 'description': 'Endovenous ablation followed by vehicle placebo', 'otherNumAtRisk': 38, 'otherNumAffected': 20, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Endovenous Ablation, Polidocanol Injectable Foam, 0.5%', 'description': 'Endovenous ablation followed by polidocanol injectable foam, 0.5%', 'otherNumAtRisk': 39, 'otherNumAffected': 29, 'seriousNumAtRisk': 39, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Endovenous Ablation, Polidocanol Injectable Foam 1.0%', 'description': 'endovenous ablation followed by polidocanol injectable foam 1.0%', 'otherNumAtRisk': 40, 'otherNumAffected': 35, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'infusion site thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'limb discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pain in extermity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thrombophlebitis superficial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Endovenous Ablation, Vehicle Placebo', 'description': 'Endovenous ablation followed by vehicle placebo'}, {'id': 'OG001', 'title': 'Endovenous Ablation, Polidocanol Injectable Foam, 0.5%', 'description': 'Endovenous ablation followed by polidocanol injectable foam, 0.5%'}, {'id': 'OG002', 'title': 'Endovenous Ablation, Polidocanol Injectable Foam 1.0%', 'description': 'endovenous ablation followed by polidocanol injectable foam 1.0%'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.102', 'groupId': 'OG000'}, {'value': '-1.30', 'spread': '0.100', 'groupId': 'OG001'}, {'value': '-1.11', 'spread': '0.097', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'IPR-V3 measured at baseline and then at 8 weeks', 'description': "The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins.", 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in PA-V3 Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Endovenous Ablation, Vehicle Placebo', 'description': 'Endovenous ablation followed by vehicle placebo'}, {'id': 'OG001', 'title': 'Endovenous Ablation, Polidocanol Injectable Foam, 0.5%', 'description': 'Endovenous ablation followed by polidocanol injectable foam, 0.5%'}, {'id': 'OG002', 'title': 'Endovenous Ablation, Polidocanol Injectable Foam 1.0%', 'description': 'endovenous ablation followed by polidocanol injectable foam 1.0%'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.59', 'spread': '0.142', 'groupId': 'OG000'}, {'value': '-1.81', 'spread': '0.140', 'groupId': 'OG001'}, {'value': '-1.85', 'spread': '0.136', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'PA-V3 measured at baseline and then at 8 weeks', 'description': 'The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4)', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Endovenous Ablation, Vehicle Placebo', 'description': 'Endovenous ablation followed by vehicle placebo'}, {'id': 'FG001', 'title': 'Endovenous Ablation, Polidocanol Injectable Foam, 0.5%', 'description': 'Endovenous ablation followed by polidocanol injectable foam, 0.5%'}, {'id': 'FG002', 'title': 'Endovenous Ablation, Polidocanol Injectable Foam 1.0%', 'description': 'endovenous ablation followed by polidocanol injectable foam 1.0%'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '39'}, {'groupId': 'FG002', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Endovenous Ablation, Vehicle Placebo', 'description': 'Endovenous ablation followed by vehicle placebo'}, {'id': 'BG001', 'title': 'Endovenous Ablation, Polidocanol Injectable Foam, 0.5%', 'description': 'Endovenous ablation followed by polidocanol injectable foam, 0.5%'}, {'id': 'BG002', 'title': 'Endovenous Ablation, Polidocanol Injectable Foam 1.0%', 'description': 'endovenous ablation followed by polidocanol injectable foam 1.0%'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.1', 'spread': '12.05', 'groupId': 'BG000'}, {'value': '50.1', 'spread': '11.60', 'groupId': 'BG001'}, {'value': '51.8', 'spread': '9.75', 'groupId': 'BG002'}, {'value': '52.0', 'spread': '11.18', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'spread': '6.04', 'groupId': 'BG000'}, {'value': '27.7', 'spread': '4.58', 'groupId': 'BG001'}, {'value': '28.1', 'spread': '5.25', 'groupId': 'BG002'}, {'value': '28.3', 'spread': '5.32', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg^m2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'all treated patients'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'dispFirstSubmitDate': '2013-07-23', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2010-09-08', 'dispFirstSubmitQcDate': '2013-12-09', 'resultsFirstSubmitDate': '2014-02-07', 'studyFirstSubmitQcDate': '2010-09-08', 'dispFirstPostDateStruct': {'date': '2014-01-09', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-09-10', 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline in Independent Photography Review (IPR-V3 Score)', 'timeFrame': 'IPR-V3 measured at baseline and then at 8 weeks', 'description': "The Independent Photography Review - Visible Varicose Veins (IPR-V3) instrument is a 5-point scale used to assess the appearance of a patient's visible varicose veins. At screening, the site clinician was instructed to review the appearance of the patient's varicose veins in the medial section of each leg (a 'live' assessment), then select an IPR-V3 score (i.e., none=0, mild, moderate, severe or very severe=4) that best represented the appearance of the patient's varicose veins. This assessment took into account the attributes caliber, dilatation, tortuosity, and extent and number of varicosities, and was used to determine patient eligibility. The site clinician used a set of reference photographs (2 example photographs for each score on the scale) to assist with assigning a score to the appearance of the patient's visible varicose veins."}, {'measure': 'Absolute Change From Baseline in PA-V3 Score', 'timeFrame': 'PA-V3 measured at baseline and then at 8 weeks', 'description': 'The Patient Self-assessment of Visible Varicose Veins (PA-V3) instrument is a 5-point scale used by patients to evaluate the appearance of their visible varicose veins. On this paper questionnaire, the instructions included a diagram of the medial view of a leg with the area between the ankle and the groin circled. The patient was instructed to choose 1 of 5 response options that best described the appearance of the visible varicose veins of the leg that was treated in the study. The patient was instructed not to consider the appearance of the leg outside the circled area or of any spider veins. Possible responses ranged from "Not at all noticeable" (a score of 0) to "Extremely noticeable" (a score of 4)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['varicose veins', 'Great saphenous vein', 'varicosities'], 'conditions': ['Great Saphenous Vein Incompetence', 'Visible Varicosities']}, 'referencesModule': {'references': [{'pmid': '26957489', 'type': 'DERIVED', 'citation': 'Vasquez M, Gasparis AP; Varithena(R) 017 Investigator Group. A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities. Phlebology. 2017 May;32(4):272-281. doi: 10.1177/0268355516637300. Epub 2016 Mar 7.'}]}, 'descriptionModule': {'briefSummary': 'Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) when used following an approved heat treatment in subjects with varicose veins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Incompetence of SFJ\n* Patients who are candidates for ETA \\[laser or radiofrequency ablation (RFA)\\]\n* Symptomatic varicose veins\n* Visible varicose veins\n* Ability to comprehend and sign an informed consent and complete study questionnaires in English\n\nExclusion Criteria:\n\n* Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders)\n* Patients who have active ulceration on the leg to be treated (Clinical Finding C6, as assessed by CEAP Classification of Venous Disorders)\n* Leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure compression bandaging and stockings\n* Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion\n* Deep venous reflux unless clinically insignificant in comparison to superficial reflux\n* Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings\n* Reduced mobility\n* History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior DVT on duplex ultrasound\n* Major surgery, prolonged hospitalization or pregnancy within 3 months of screening\n* Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)\n* Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions\n* Current alcohol or drug abuse\n* Pregnant or lactating women\n* Women of childbearing potential not using effective contraception'}, 'identificationModule': {'nctId': 'NCT01197833', 'acronym': '017', 'briefTitle': 'Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'A Multicenter, Randomized, Blinded Study of Endovenous Thermal Ablation With or Without Varisolve™ Polidocanol Endovenous Microfoam (PEM) Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities', 'orgStudyIdInfo': {'id': 'VAP.VV017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endovenous ablation+polidocanol injectable microfoam 0.125%', 'description': 'Endovenous ablation followed by an injection of polidocanol injectable microfoam 0.125% to target vein', 'interventionNames': ['Drug: endovenous ablation+polidocanol injectable microfoam 0.125%']}, {'type': 'EXPERIMENTAL', 'label': 'Endovenous ablation+polidocanol injectable micrfoam, 1.0%', 'description': 'Endovenous ablation followed by injection of polidocanol injectable microfoam, 1.0% to the target vein', 'interventionNames': ['Drug: Endovenous ablation+polidocanol injectable microfoam 1.0%']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'endovenous ablation+vehicle (placebo)', 'description': 'endovenous ablation followed by injection of vehicle (placebo) to target vein', 'interventionNames': ['Drug: Endovenous ablation+polidocanol injectable foam 2.0%']}], 'interventions': [{'name': 'endovenous ablation+polidocanol injectable microfoam 0.125%', 'type': 'DRUG', 'otherNames': ['endovenous ablation followed by polidocanol endovenous microfoam 0.125% injection to target vein'], 'description': 'All components except API', 'armGroupLabels': ['Endovenous ablation+polidocanol injectable microfoam 0.125%']}, {'name': 'Endovenous ablation+polidocanol injectable microfoam 1.0%', 'type': 'DRUG', 'otherNames': ['Endovenous ablation followed by injection of polidocanol injectable foam 1.0% to target vein'], 'description': 'endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0%', 'armGroupLabels': ['Endovenous ablation+polidocanol injectable micrfoam, 1.0%']}, {'name': 'Endovenous ablation+polidocanol injectable foam 2.0%', 'type': 'DRUG', 'otherNames': ['Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%'], 'description': 'Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%', 'armGroupLabels': ['endovenous ablation+vehicle (placebo)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85255', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '60523', 'city': 'Oak Brook', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.83281, 'lon': -87.92895}}, {'zip': '14120', 'city': 'North Tonawanda', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.03867, 'lon': -78.8642}}, {'zip': '11974', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '98034', 'city': 'Kirkland', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.68149, 'lon': -122.20874}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}