Vulvar DysplasiaPhase 3NCT00394758
A Randomized Trial of Surgical Treatments for Vulvar and Vaginal Dysplasia
A Phase 3 study testing CO2 laser surgery and ultrasonic surgical aspiration in people with Vulvar Dysplasia and Vaginal Dysplasia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Dysplasia, Vaginal Dysplasia
- What is being tested?
- CO2 laser surgery and ultrasonic surgical aspiration
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2000to 31 Dec 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients under the age of eighteen or who are pregnant will be excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
Official title: Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias
- To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias
- To compare healing related complications, post-operative pain, and scarring between the two procedures.
Read the 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:
- 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.
- To compare healing related complications, post-operative pain, and scarring between the two procedures.
- Conditions
- Vulvar Dysplasia, Vaginal Dysplasia
- Being tested
- CO2 laser surgery, ultrasonic surgical aspiration
- Keywords
- ultrasonic surgical aspiration, CO2 laser surgery, vulvar dysplasia, vaginal dysplasia, recurrence
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 laser surgeryProcedure or surgery
ultrasonic surgical aspirationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence rate
Secondary outcomes (3)
pain
side effects
complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2006 (estimated)
- Study start1 Jan 2000
- Primary completion31 Dec 2005
- Study completion31 Dec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vulvar DysplasiaStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian von Gruenigen, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00394758
- Sponsor's protocol ID
- CASE 4804
- Status last verified
- May 2022
- First submitted
- 30 Oct 2006
- Last updated
- 12 May 2022
- Results posted
- No
Publications
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.
PubMed 17400858
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Procedures in Vulvar and Vaginal Dysplasias
- ClinicalTrials.gov ID
- NCT00394758
- Acronym / sponsor ID
- CASE 4804
- Conditions
- Vulvar Dysplasia, Vaginal Dysplasia
- Keywords
- ultrasonic surgical aspiration, CO2 laser surgery, vulvar dysplasia, vaginal dysplasia, recurrence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 31 Dec 2005 (actual)
- Study completion
- 31 Dec 2005 (actual)
- First posted
- 1 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To compare the recurrence rate between the use of laser vaporization and ultrasonic surgical aspiration in the treatment of vulvar and vaginal dysplasias
- 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:
- 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.
- To compare healing related complications, post-operative pain, and scarring between the two procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients under the age of eighteen or who are pregnant will be excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CO2 laser surgery | Procedure or surgery | – |
| ultrasonic surgical aspiration | Procedure or surgery | – |
Primary outcome
recurrence rate
3 secondary outcomes
pain
side effects
complications
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 17400858von 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.
Related trials for Vulvar Dysplasia
RecruitingObservational study
Evaluation of a Point-of-Care, AI-Powered Spectroscopy Device for Triage of Suspicious Vulvar Lesions: A Pilot Study
Vulvar Intraepithelial Neoplasia, HPV-Independent, Vulvar Squamous Cell Carcinoma
Not yet recruiting
Needlefree Lidocaine Application for Vulvar Biopsies
Vulvar Cancers, Vulva Neoplasm
RecruitingObservational study
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
Cancer Risk, Cancer Predisposition Syndrome
RecruitingPhase 2
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
Vulvar Diseases, HPV Infection
Recruiting
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
Vulvar Cancer, Cervical Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian von Gruenigen, MD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CO2 laser surgery and ultrasonic surgical aspiration in people with Vulvar Dysplasia and Vaginal Dysplasia, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00394758, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.