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A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia

University Hospitals (UH) logo

University Hospitals (UH)

Status and phase

Completed
Phase 3

Conditions

Vulvar Dysplasia
Vaginal Dysplasia

Treatments

Procedure: CO2 laser surgery
Procedure: ultrasonic surgical aspiration

Study type

Interventional

Funder types

Other

Identifiers

NCT00394758
CASE 4804

Details and patient eligibility

About

  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.

Full 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.

Enrollment

150 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 criteria

  • Patients under the age of eighteen or who are pregnant will be excluded

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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