Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-01-03 @ 7:54 PM
Study NCT ID:
NCT02875561
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2016-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
Sponsor:
Organization:
Raw JSON
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compared to CO2 Laser Ablation', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 12, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CO2 Laser Ablation', 'description': 'Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nCO2 Laser Ablation: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 18, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'vaginal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anal pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'yeast infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'itching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'soreness at site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Recurrence of Dysplasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sonopet Ultrasonic Aspirator', 'description': 'Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nSonopet Ultrasonic Aspirator: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation'}, {'id': 'OG001', 'title': 'CO2 Laser Ablation', 'description': 'Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nCO2 Laser Ablation: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Number of participants with recurrence of dysplasia time point 12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Scarring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sonopet Ultrasonic Aspirator', 'description': 'Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nSonopet Ultrasonic Aspirator: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation'}, {'id': 'OG001', 'title': 'CO2 Laser Ablation', 'description': 'Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nCO2 Laser Ablation: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 weeks', 'description': 'Physical evaluation for scarring', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Sexual Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sonopet Ultrasonic Aspirator', 'description': 'Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nSonopet Ultrasonic Aspirator: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation'}, {'id': 'OG001', 'title': 'CO2 Laser Ablation', 'description': 'Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nCO2 Laser Ablation: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.9', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '9.5', 'groupId': 'OG001'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.3', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '19.8', 'spread': '10.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (enrollment), 12 months', 'description': 'Evaluated by Female Sexual Function Index Scale Title: Female Sexual Function Index (FSFI) Minimum value: 2.0 Maximum value: 36.0 a score of 0 in any domain correlates to no sexual activity. a score of 0 in any domain correlates to no sexual activity in that domain alone, and is not indicative of the total score. Lower scores indicate worse sexual function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all surveys at all timepoints were optional. Some participants completed all surveys, some completed only baseline surveys and some only completed end of study surveys. This is why the population varies between timepoints.'}, {'type': 'SECONDARY', 'title': 'Changes in Mental and Physical Wellness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Sonopet Ultrasonic Aspirator', 'description': 'Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nSonopet Ultrasonic Aspirator: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation'}, {'id': 'OG001', 'title': 'CO2 Laser Ablation', 'description': 'Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nCO2 Laser Ablation: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '155.6', 'spread': '29.8', 'groupId': 'OG000'}, {'value': '145', 'spread': '29.1', 'groupId': 'OG001'}]}]}, {'title': 'End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '147', 'spread': '26.4', 'groupId': 'OG000'}, {'value': '156.5', 'spread': '20.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (enrollment), End of Study (12 months)', 'description': 'Evaluated by Functional Assessment of Cancer Therapy - Vulva (FACT-V) health survey for vulva disease Scale Title: Functional Assessment of Cancer Therapy - Vulva (FACT-V) High score correlates to better quality of life. This survey uses a 5-point Likert type scale. Minimum score: 0 Maximum score: 184', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all surveys at all timepoints were optional. Some participants completed all surveys, some completed only baseline surveys and some only completed end of study surveys. This is why the population varies between timepoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sonopet Ultrasonic Aspirator', 'description': 'Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nSonopet Ultrasonic Aspirator: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation'}, {'id': 'FG001', 'title': 'CO2 Laser Ablation', 'description': 'Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nCO2 Laser Ablation: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sonopet Ultrasonic Aspirator', 'description': 'Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nSonopet Ultrasonic Aspirator: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation'}, {'id': 'BG001', 'title': 'CO2 Laser Ablation', 'description': 'Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation\n\nCO2 Laser Ablation: To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation'}, {'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': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', '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': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '44', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-12', 'size': 685726, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-08-11T21:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2016-08-18', 'resultsFirstSubmitDate': '2023-08-14', 'studyFirstSubmitQcDate': '2016-08-18', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-30', 'studyFirstPostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Recurrence of Dysplasia', 'timeFrame': '12 months', 'description': 'Number of participants with recurrence of dysplasia time point 12 months'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Scarring', 'timeFrame': '6 weeks', 'description': 'Physical evaluation for scarring'}, {'measure': 'Changes in Sexual Function', 'timeFrame': 'Baseline (enrollment), 12 months', 'description': 'Evaluated by Female Sexual Function Index Scale Title: Female Sexual Function Index (FSFI) Minimum value: 2.0 Maximum value: 36.0 a score of 0 in any domain correlates to no sexual activity. a score of 0 in any domain correlates to no sexual activity in that domain alone, and is not indicative of the total score. Lower scores indicate worse sexual function.'}, {'measure': 'Changes in Mental and Physical Wellness', 'timeFrame': 'Baseline (enrollment), End of Study (12 months)', 'description': 'Evaluated by Functional Assessment of Cancer Therapy - Vulva (FACT-V) health survey for vulva disease Scale Title: Functional Assessment of Cancer Therapy - Vulva (FACT-V) High score correlates to better quality of life. This survey uses a 5-point Likert type scale. Minimum score: 0 Maximum score: 184'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Vulvar Intraepithelial Neoplasia (VIN)']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspiration.', 'detailedDescription': 'Incidence of Vulvar Intraepithelial Neoplasia (VIN) is increasing among women and there still lacks a standard of care for optimal treatment. Current treatment options aim to treat the symptoms associated with VIN and result in a high recurrence rate. Due to the high reoccurrence rate and the nature of the current treatments, a more effective treatment option is warranted. An effective treatment that targets only the diseased areas could potentially decrease recurrence rates. Additionally, a more conservative treatment modality could contribute to reduced risks of scarring, discomfort, and psychosocial and sexual distraught. The researchers hypothesize that treatment for VIN with ultrasonic aspiration will have a 60% reduction in recurrence rates over 12 months as compared to CO2 laser aspiration.\n\nThis study will employ a randomized controlled trial (RCT) design. This is a phase III study to determine the effectiveness of a more targeted treatment therapy for VIN (comparing ultrasonic aspiration versus CO2 laser ablation). Potential participants will be identified through the gynecological clinical practices following diagnosis of high grade VIN and will be randomized (1:1) to one of the treatment therapies. Randomization will be stratified for multi-focal disease and Human Papillomavirus (HPV) status. Both the Sonopet Ultrasonic Aspirator and the CO2 laser ablation devices are FDA approved devices for the treatment of vulvar dysplasia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18-89 years old\n* Women diagnosed with high-grade VIN (diagnosed by pathology)\n* Women referred for vulva sparing treatment for dysplasia\n* Women available for follow-up of treatment for 12 months\n\nExclusion Criteria:\n\n* Women who are pregnant\n* Women with low-grade VIN dysplasia (diagnosed by pathology)\n* Women with vaginal intraepithelial neoplasia(VAIN)\n* Women requiring vulvectomy for treatment\n* Women unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02875561', 'briefTitle': 'Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'A Randomized Controlled Trial of Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia', 'orgStudyIdInfo': {'id': '16-0701.cc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sonopet Ultrasonic Aspirator', 'description': 'Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation', 'interventionNames': ['Device: Sonopet Ultrasonic Aspirator']}, {'type': 'EXPERIMENTAL', 'label': 'CO2 Laser Ablation', 'description': 'Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation', 'interventionNames': ['Device: CO2 Laser Ablation']}], 'interventions': [{'name': 'Sonopet Ultrasonic Aspirator', 'type': 'DEVICE', 'description': 'To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation', 'armGroupLabels': ['Sonopet Ultrasonic Aspirator']}, {'name': 'CO2 Laser Ablation', 'type': 'DEVICE', 'description': 'To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation', 'armGroupLabels': ['CO2 Laser Ablation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '73019', 'city': 'Norman', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.22257, 'lon': -97.43948}}], 'overallOfficials': [{'name': 'Saketh Guntupalli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Stryker Instruments', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}