NCT00394758

Brief Summary

  1. 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. 2.To compare healing related complications, post-operative pain, and scarring between the two procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2006

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

6 years

First QC Date

October 30, 2006

Last Update Submit

May 6, 2022

Conditions

Vulvar DysplasiaVaginal Dysplasia

Keywords

ultrasonic surgical aspirationCO2 laser surgeryvulvar dysplasiavaginal dysplasiarecurrence

Outcome Measures

Primary Outcomes (1)

  • recurrence rate

Secondary Outcomes (3)

  • pain

  • side effects

  • complications

Interventions

CO2 laser surgeryPROCEDURE
ultrasonic surgical aspirationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • 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.

    PMID: 17400858DERIVED

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Vivian von Gruenigen, MD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2006

First Posted

November 1, 2006

Study Start

January 1, 2000

Primary Completion

December 31, 2005

Study Completion

December 31, 2005

Last Updated

May 12, 2022

Record last verified: 2022-05

Locations

US(1)