Status:
COMPLETED
A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia
Lead Sponsor:
University Hospitals Cleveland Medical Center
Conditions:
Vulvar Dysplasia
Vaginal Dysplasia
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
1. To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias 2. To compare healing related complications...
Detailed Description
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 acce...
Eligibility Criteria
Inclusion
- Patients who present with vulvar or vaginal dysplasias or condylomas that require surgical intervention will be informed of the study by the treating physician
- 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.
Exclusion
- Patients under the age of eighteen or who are pregnant will be excluded
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2005
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00394758
Start Date
January 1 2000
End Date
December 31 2005
Last Update
May 12 2022
Active Locations (1)
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1
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106