Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-29 @ 10:43 PM
Study NCT ID:
NCT00394758
Status:
COMPLETED
Last Update Posted:
2022-05-12
First Post:
2006-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2005-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-06', 'studyFirstSubmitDate': '2006-10-30', 'studyFirstSubmitQcDate': '2006-10-30', 'lastUpdatePostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence rate'}], 'secondaryOutcomes': [{'measure': 'pain'}, {'measure': 'side effects'}, {'measure': 'complications'}]}, 'conditionsModule': {'keywords': ['ultrasonic surgical aspiration', 'CO2 laser surgery', 'vulvar dysplasia', 'vaginal dysplasia', 'recurrence'], 'conditions': ['Vulvar Dysplasia', 'Vaginal Dysplasia']}, 'referencesModule': {'references': [{'pmid': '17400858', 'type': 'DERIVED', 'citation': 'von Gruenigen VE, Gibbons HE, Gibbins K, Jenison EL, Hopkins MP. Surgical treatments for vulvar and vaginal dysplasia: a randomized controlled trial. Obstet Gynecol. 2007 Apr;109(4):942-7. doi: 10.1097/01.AOG.0000258783.49564.5c.'}]}, 'descriptionModule': {'briefSummary': '1. To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias\n2. To compare healing related complications, post-operative pain, and scarring between the two procedures.', 'detailedDescription': 'First line of treatment for vulvar intraepithelial neoplasia (VIN) and vaginal intraepithelial neoplasia (VAIN) is not well defined. Laser vaporization and ultrasonic surgical aspiration are both accepted surgical modalities used in the treatment of vulvar and vaginal dysplasias, however no prospective study has been done to compare the two procedures. The specific aims of this research study include:\n\n1. To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias in a prospective, multi-institutional, randomized clinical trial.\n2. To compare healing related complications, post-operative pain, and scarring between the two procedures.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who present with vulvar or vaginal dysplasias or condylomas that require surgical intervention will be informed of the study by the treating physician\n* Pre-operative biopsies to confirm presence of dysplasia / condyloma. Patients with dysplasias of grade 3 / CIS will be included at the discretion of the treating surgeon and will have had invasion confidently excluded by clinical exam and biopsy.\n\nExclusion Criteria:\n\n* Patients under the age of eighteen or who are pregnant will be excluded'}, 'identificationModule': {'nctId': 'NCT00394758', 'briefTitle': 'A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias', 'orgStudyIdInfo': {'id': 'CASE 4804'}}, 'armsInterventionsModule': {'interventions': [{'name': 'CO2 laser surgery', 'type': 'PROCEDURE'}, {'name': 'ultrasonic surgical aspiration', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Vivian von Gruenigen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}