Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-03-05 @ 5:06 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:
University Hospitals Cleveland Medical Center
Organization:
Study Overview
Official Title:
Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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, post-operative pain, and scarring between the two procedures.
2. To compare healing related complications, post-operative pain, and scarring between the two procedures.
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 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:
1. 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.
2. To compare healing related complications, post-operative pain, and scarring between the two procedures.
1. 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.
2. To compare healing related complications, post-operative pain, and scarring between the two procedures.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: