Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT03311269
Status:
TERMINATED
Last Update Posted:
2022-03-02
First Post:
2017-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2020-06-02', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D014689', 'term': 'Venous Insufficiency'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012981', 'term': 'Sodium Tetradecyl Sulfate'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'C046259', 'term': '3-methoxy-14,15-methyleneestra-1,3,5-triene-17-ol'}], 'ancestors': [{'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000476', 'term': 'Alkanesulfonates'}, {'id': 'D017738', 'term': 'Alkanesulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lorraine.hanley@merit.com', 'phone': '617-519-1109', 'title': 'Ms. Lorraine Hanley, MBA', 'organization': 'Vascular Inisights, LLC'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'A total of 19 subjects were enrolled in the study. The study was terminated for administrative reasons; there were no safety or efficacy concerns. It was determined by the sponsor that the Phase 3 protocol, which is designed to closely mimic the Phase 2 protocol, would be adequate to collect safety and efficacy assessments with minor adjustments.'}}, 'adverseEventsModule': {'timeFrame': "AE data collection began after ICF is signed and continued until completion of subject's Week 12 post-treatment follow-up visit (Visit 6). Any AE or SAE having an onset after the completion of Visit 6 (end of the study visit) was not collected or reported unless the Investigator determined event to be related to the study drug.", 'eventGroups': [{'id': 'EG000', 'title': 'ClariVein RES 1% Injection', 'description': 'Sodium Tetradecyl Sulfate 1% Injection single administration\n\nClariVein RES: ClariVein system\n\nSodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'ClariVein RES 3% Injection', 'description': 'Sodium Tetradecyl Sulfate 3% Injection single administration\n\nClariVein RES: ClariVein system\n\nSodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Blister', 'notes': 'Blister (From Compression Sock)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thrombophlebitis Superficial', 'notes': 'superficial thrombophlebitis.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Infusion Site Bruising', 'notes': 'Bruising at Access Site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ClariVein RES 1% Injection', 'description': 'Sodium Tetradecyl Sulfate 1% Injection single administration\n\nClariVein RES: ClariVein system\n\nSodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection'}, {'id': 'OG001', 'title': 'ClariVein RES 3% Injection', 'description': 'Sodium Tetradecyl Sulfate 3% Injection single administration\n\nClariVein RES: ClariVein system\n\nSodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '3.00', 'groupId': 'OG000'}, {'value': '6.2', 'spread': '1.87', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.2', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '-2.3', 'pValueComment': 'This p-value corresponds to the change from Baseline to Week 12 for both treatment groups (ClariVein RES 1% Injection and ClariVein RES 3% Injection) combined.', 'groupDescription': 'Continuous variables summarized using descriptive statistics, specifically the mean, median, standard deviation, minimum and maximum. Categorical variables summarized using frequencies and percentages. All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated. For efficacy analyses, missing post-treatment data will be imputed using last observation carried forward (LOCF). Missing safety data will not be imputed.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'One-Sample', 'nonInferiorityComment': 'The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.'}, {'pValue': '0.011', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-5.8', 'ciUpperLimit': '-1.0', 'pValueComment': 'This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 1% Injection treatment group.', 'groupDescription': 'All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'One-Sample', 'nonInferiorityComment': 'The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.'}, {'pValue': '0.010', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.1', 'ciLowerLimit': '-8.7', 'ciUpperLimit': '-1.6', 'pValueComment': 'This p-value corresponds to the change from Baseline to Week 12 for the ClariVein RES 3% Injection treatment group.', 'groupDescription': 'All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'One-Sample', 'nonInferiorityComment': 'The null hypothesis is that the mean change from baseline for the primary efficacy endpoint=0. The alternative hypothesis is that the mean change does not =0. The primary analysis will be a one-sample t-test for both treatment groups combined, to test the null hypothesis that the mean change from baseline equals 0. Primary analysis will be performed for each treatment group separately.'}, {'pValue': '0.531', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '1.3', 'pValueComment': 'This p-value corresponds to the difference between treatment groups (ClariVein RES 1% Injection versus ClariVein RES 3% Injection).', 'groupDescription': 'All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'An ANCOVA was performed to compare the change from baseline for ClariVein RES 1% Injection versus ClariVein RES 3% Injection with treatment as the class variable and with baseline score as the covariate'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'The VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study Quality of Life) comprises 25 items that quantify disease effect on quality-of-life, \\& a symptom questionnaire (VEINES-Sym) with 10 items that measure physical symptoms. A subset of the reported symptoms to Question 1 of the VEINES QOL/Sym is referred to as the 7-Day Symptom Questionnaire was used in this study. Subject response to each symptom was rated on a common 4-point response scale with lower scores representing better daily health outcomes (4=all day, 3=several times today, 2=once today, 1=not today). Weekly average score was calculated if at least 4 daily scores were present in the previous week. Daily total symptom score derived as sum of the responses across all symptoms (range = 5 to 20) Improvement in patient reported symptoms using the 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing \\& Itching) at post-treatment Week 12 compared to Baseline is the primary endpoint of this study.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Elimination of Saphenous Vein Reflux', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ClariVein RES 1% Injection', 'description': 'Sodium Tetradecyl Sulfate 1% Injection single administration\n\nClariVein RES: ClariVein system\n\nSodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection'}, {'id': 'OG001', 'title': 'ClariVein RES 3% Injection', 'description': 'Sodium Tetradecyl Sulfate 3% Injection single administration\n\nClariVein RES: ClariVein system\n\nSodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection'}], 'classes': [{'title': 'Vein Closure : Yes', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Vein Closure : No', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vein Closure : Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vein Competency : Yes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vein Competency : No', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vein Competency : Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Vein Competency: No open segments > 5cm', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Saphenous Vein Reflux: Non-Responder', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Saphenous Vein Reflux: Responder', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Descriptive (Percentage)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '94.4', 'ciLowerLimit': '72.7', 'ciUpperLimit': '99.9', 'estimateComment': 'The count of the combined treatment group for the elimination of saphenous vein reflux at Week 12 posttreatment is 17/18 (94.4%).', 'groupDescription': 'The secondary efficacy endpoint, the elimination of saphenous vein reflux at Week 12 posttreatment, will be summarized for both treatments combined using the count and percentage, together with a 95% Wilson (score) confidence interval for the proportion.', 'nonInferiorityType': 'OTHER'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.1', 'ciLowerLimit': '-20.5', 'ciUpperLimit': '42.8', 'pValueComment': 'All statistical tests will be performed at the 0.05 significance level (p -value ≤ 0.050) unless otherwise indicated.', 'groupDescription': 'For elimination of saphenous vein reflux at Week 12 posttreatment, the treatment difference for ClariVein RES 1% Injection versus ClariVein RES 3% Injection for the proportion was assessed by a chi-square test together with a 95% Wilson (score) confidence interval for the treatment difference.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Evaluated by way of duplex ultrasound and read by Core Lab. Elimination of saphenous vein reflux can be achieved when ultrasound images demonstrate vein closure (no discrete open segment of vein \\> 5cm in length within the treatment section of the selected saphenous vein), or vein competency (defined as absence of retrograde flow \\> 0.5 seconds within any open portions of the treatment section of the selected saphenous vein) as assessed by duplex ultrasound. Responder = subjects who satisfies criteria for elimination of saphenous vein reflux', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ClariVein RES 1% Injection', 'description': 'Sodium Tetradecyl Sulfate 1% Injection single administration\n\nClariVein RES: ClariVein system\n\nSodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection'}, {'id': 'FG001', 'title': 'ClariVein RES 3% Injection', 'description': 'Sodium Tetradecyl Sulfate 3% Injection single administration\n\nClariVein RES: ClariVein system\n\nSodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ClariVein RES 1% Injection', 'description': 'Sodium Tetradecyl Sulfate 1% Injection single administration\n\nClariVein RES: ClariVein system\n\nSodium Tetradecyl Sulfate 1% Injection: Sodium Tetradecyl Sulfate STS 1% Injection'}, {'id': 'BG001', 'title': 'ClariVein RES 3% Injection', 'description': 'Sodium Tetradecyl Sulfate 3% Injection single administration\n\nClariVein RES: ClariVein system\n\nSodium Tetradecyl Sulfate 3% Injection: Sodium Tetradecyl Sulfate 3% Injection'}, {'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': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '25.6', 'spread': '4.54', 'groupId': 'BG000'}, {'value': '27.1', 'spread': '5.35', 'groupId': 'BG001'}, {'value': '26.3', 'spread': '4.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Ultrasound Parameters at Screening: Leg Assessed', 'classes': [{'categories': [{'title': 'Right', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Left', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Retrograde Flow', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Patient-Reported Symptoms 7-Day Symptom Questionnaire (Average Daily Total Symptom Score', 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'spread': '3.39', 'groupId': 'BG000'}, {'value': '11.3', 'spread': '4.18', 'groupId': 'BG001'}, {'value': '10.9', 'spread': '3.76', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '7 Day Symptom Questionnaire. Subjects self reported each symptom on a daily basis for 7 consecutive days prior to study day 1. Response to each system was rated on a common 4-point response scale, with lower scores representing better daily health outcomes (4=all day, 3=several times today, 2=once today, 1=not today). Mean is calculated across daily responses for each of the symptoms. Weekly average score was calculated if at least 4 daily scores were present. Daily total symptom score is derived as sum of responses across all symptoms (range 5 to 20). More than 2 items missing, then no score', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Saphenous Vein Reflux', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Evaluated by way of duplex ultrasound and read by Core Lab. Elimination of saphenous vein reflux can be achieved when ultrasound images demonstrate vein closure (no discrete open segment of vein \\> 5cm in length within the treatment section of the selected saphenous vein), or vein competency (defined as absence of retrograde flow \\> 0.5 seconds within any open portions of the treatment section of the selected saphenous vein) as assessed by duplex ultrasound. Responder = subjects who satisfies criteria for elimination of saphenous vein reflux', 'unitOfMeasure': 'Participants'}, {'title': 'Length of Vein Section to be Treated', 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'spread': '6.49', 'groupId': 'BG000'}, {'value': '34.6', 'spread': '15.27', 'groupId': 'BG001'}, {'value': '36.3', 'spread': '11.29', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diameter of Vein Section to be Treated', 'classes': [{'categories': [{'measurements': [{'value': '5.41', 'spread': '0.845', 'groupId': 'BG000'}, {'value': '9.08', 'spread': '7.490', 'groupId': 'BG001'}, {'value': '7.15', 'spread': '5.369', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-11', 'size': 883595, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-15T17:27', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'whyStopped': 'Study was terminated for administrative reasons', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2017-10-11', 'resultsFirstSubmitDate': '2020-05-15', 'studyFirstSubmitQcDate': '2017-10-11', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-02-09', 'studyFirstPostDateStruct': {'date': '2017-10-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient-Reported Symptoms 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing & Itching) to Evaluate Improvement in Subject Reported Symptoms.', 'timeFrame': '12 weeks', 'description': 'The VEINES-QOL (VEnous INsufficiency Epidemiological and Economic Study Quality of Life) comprises 25 items that quantify disease effect on quality-of-life, \\& a symptom questionnaire (VEINES-Sym) with 10 items that measure physical symptoms. A subset of the reported symptoms to Question 1 of the VEINES QOL/Sym is referred to as the 7-Day Symptom Questionnaire was used in this study. Subject response to each symptom was rated on a common 4-point response scale with lower scores representing better daily health outcomes (4=all day, 3=several times today, 2=once today, 1=not today). Weekly average score was calculated if at least 4 daily scores were present in the previous week. Daily total symptom score derived as sum of the responses across all symptoms (range = 5 to 20) Improvement in patient reported symptoms using the 7-Day Symptom Questionnaire (Heaviness, Achiness, Swelling, Throbbing \\& Itching) at post-treatment Week 12 compared to Baseline is the primary endpoint of this study.'}], 'secondaryOutcomes': [{'measure': 'Elimination of Saphenous Vein Reflux', 'timeFrame': '12 weeks', 'description': 'Evaluated by way of duplex ultrasound and read by Core Lab. Elimination of saphenous vein reflux can be achieved when ultrasound images demonstrate vein closure (no discrete open segment of vein \\> 5cm in length within the treatment section of the selected saphenous vein), or vein competency (defined as absence of retrograde flow \\> 0.5 seconds within any open portions of the treatment section of the selected saphenous vein) as assessed by duplex ultrasound. Responder = subjects who satisfies criteria for elimination of saphenous vein reflux'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Venous Insufficiency']}, 'descriptionModule': {'briefSummary': 'VICARES is a prospective randomized, controlled, multi-center, double blind study treating venous insufficiency associated with incompetent saphenous veins with 1% and 3% Sodium Tetradecyl Sulfate (STS) solution utilizing the ClariVein system.', 'detailedDescription': 'Approximately 50 subjects diagnosed with an incompetent saphenous vein will be randomized to either 1% STS or 3% STS solution delivered by the ClariVein system under ultrasound guidance.\n\nStudy duration for individual study patients, including follow-up visits, is anticipated to be approximately 16 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patient with incompetent saphenous vein\n2. Saphenous vein reflux \\> 500ms (0.5s), as measured by duplex ultrasound\n3. One or more of patient reported symptoms related to the target vein: i.e., heaviness, achiness, swelling, throbbing or itching.\n4. Candidate for endovenous procedure\n\nExclusion Criteria:\n\n1. Arterial insufficiency demonstrated by a history of peripheral arterial disease (PAD) that would preclude the wearing of compression stockings\n2. Absence of a palpable pulse at posterior tibial or dorsalis pedis and an Ankle-Brachial Index (ABI) \\<0.6\n3. Multi-segmental axial deep venous reflux in at least two contiguous venous segments (e.g., femoral and popliteal) in the ipsilateral extremity\n4. Previous surgical or endovenous procedure in the treatment section of the target vein\n5. Previous superficial thrombophlebitis of the target saphenous vein with scarring in the treatment section\n6. Pregnant or breastfeeding\n7. Known sensitivity or allergic response to Sodium Tetradecyl Sulfate (STS)\n8. Known high risk of thrombosis\n9. Known history of deep vein thrombus (DVT) or pulmonary embolism (PE), known history of acute superficial vein thrombus, known hypercoagulable condition, post thrombotic syndrome\n10. Known history of anaphylaxis or presence of multiple severe allergies'}, 'identificationModule': {'nctId': 'NCT03311269', 'acronym': 'VICARES', 'briefTitle': 'A Study Evaluating ClariVein With a Sclerosing Agent for the Treatment of Venous Insufficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vascular Insights, LLC'}, 'officialTitle': 'A Prospective, Randomized, Controlled, Multi-Center, Double Blind Study of ClariVein RES for Treatment of Venous Insufficiency Associated With Incompetent Saphenous Veins Due to Superficial Venous Reflux', 'orgStudyIdInfo': {'id': 'CL-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ClariVein RES 1% Injection', 'description': 'Sodium Tetradecyl Sulfate 1% Injection single administration', 'interventionNames': ['Device: ClariVein RES', 'Drug: Sodium Tetradecyl Sulfate 1% Injection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ClariVein RES 3% Injection', 'description': 'Sodium Tetradecyl Sulfate 3% Injection single administration', 'interventionNames': ['Device: ClariVein RES', 'Drug: Sodium Tetradecyl Sulfate 3% Injection']}], 'interventions': [{'name': 'ClariVein RES', 'type': 'DEVICE', 'description': 'ClariVein system', 'armGroupLabels': ['ClariVein RES 1% Injection', 'ClariVein RES 3% Injection']}, {'name': 'Sodium Tetradecyl Sulfate 1% Injection', 'type': 'DRUG', 'otherNames': ['STS 1%'], 'description': 'Sodium Tetradecyl Sulfate STS 1% Injection', 'armGroupLabels': ['ClariVein RES 1% Injection']}, {'name': 'Sodium Tetradecyl Sulfate 3% Injection', 'type': 'DRUG', 'otherNames': ['STS 3%'], 'description': 'Sodium Tetradecyl Sulfate 3% Injection', 'armGroupLabels': ['ClariVein RES 3% Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06820', 'city': 'Darien', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Vascular Experts', 'geoPoint': {'lat': 41.07871, 'lon': -73.46929}}, {'zip': '21702', 'city': 'Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': 'Capitol Vein and Laser Centers', 'geoPoint': {'lat': 39.41427, 'lon': -77.41054}}, {'zip': '02601', 'city': 'Hyannis', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Southeastern Surgical Associates', 'geoPoint': {'lat': 41.65289, 'lon': -70.2828}}, {'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Englegwood Hospital and Medical Center', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'facility': 'Lake Washington Vascular, PLLC', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}], 'overallOfficials': [{'name': 'Mark H Meissner, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Vascular and Endovascular Surgery Clinic at UWMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vascular Insights, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}