Vulvar Intraepithelial Neoplasia (VIN)NCT02875561
Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
A study testing Sonopet Ultrasonic Aspirator and CO2 Laser Ablation in people with Vulvar Intraepithelial Neoplasia (VIN), run by University of Colorado, Denver at 2 sites in United States.
Trial summary
The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspiration. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Vulvar Intraepithelial Neoplasia (VIN)
- What is being tested?
- Sonopet Ultrasonic Aspirator and CO2 Laser Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Mar 2017to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women 18-89 years old
- Women diagnosed with high-grade VIN (diagnosed by pathology)
- Women referred for vulva sparing treatment for dysplasia
- Women available for follow-up of treatment for 12 months
Who cannot join
- Women who are pregnant
- Women with low-grade VIN dysplasia (diagnosed by pathology)
- Women with vaginal intraepithelial neoplasia(VAIN)
- Women requiring vulvectomy for treatment
- Women unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver
Aurora, Colorado, 80045
University of Oklahoma
Norman, Oklahoma, 73019
About this study
Official title: A Randomized Controlled Trial of Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspiration.
Read the detailed description
Incidence of Vulvar Intraepithelial Neoplasia (VIN) is increasing among women and there still lacks a standard of care for optimal treatment. Current treatment options aim to treat the symptoms associated with VIN and result in a high recurrence rate. Due to the high reoccurrence rate and the nature of the current treatments, a more effective treatment option is warranted. An effective treatment that targets only the diseased areas could potentially decrease recurrence rates. Additionally, a more conservative treatment modality could contribute to reduced risks of scarring, discomfort, and psychosocial and sexual distraught. The researchers hypothesize that treatment for VIN with ultrasonic aspiration will have a 60% reduction in recurrence rates over 12 months as compared to CO2 laser aspiration.
This study will employ a randomized controlled trial (RCT) design. This is a phase III study to determine the effectiveness of a more targeted treatment therapy for VIN (comparing ultrasonic aspiration versus CO2 laser ablation). Potential participants will be identified through the gynecological clinical practices following diagnosis of high grade VIN and will be randomized (1:1) to one of the treatment therapies. Randomization will be stratified for multi-focal disease and Human Papillomavirus (HPV) status. Both the Sonopet Ultrasonic Aspirator and the CO2 laser ablation devices are FDA approved devices for the treatment of vulvar dysplasia.
- Conditions
- Vulvar Intraepithelial Neoplasia (VIN)
- Being tested
- Sonopet Ultrasonic Aspirator, CO2 Laser Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonopet Ultrasonic AspiratorDevice
To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
CO2 Laser AblationDevice
To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
| Study group | Role | What they receive |
|---|---|---|
| Sonopet Ultrasonic Aspirator | Active comparator | Treatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation Receives: Device: Sonopet Ultrasonic Aspirator |
| CO2 Laser Ablation | Experimental | Treatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation Receives: Device: CO2 Laser Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Recurrence of Dysplasia
Number of participants with recurrence of dysplasia time point 12 months
Measured: 12 months
Secondary outcomes (3)
Number of Participants With Scarring
Physical evaluation for scarring
Measured: 6 weeks
Changes in Sexual Function
Evaluated by Female Sexual Function Index Scale Title: Female Sexual Function Index (FSFI) Minimum value: 2.0 Maximum value: 36.0 a score of 0 in any domain correlates to no sexual activity. a score of 0 in any domain correlates to no sexual activity in that domain alone, and is not indicative of the total score. Lower scores indicate worse sexual function.
Measured: Baseline (enrollment), 12 months
Changes in Mental and Physical Wellness
Evaluated by Functional Assessment of Cancer Therapy - Vulva (FACT-V) health survey for vulva disease Scale Title: Functional Assessment of Cancer Therapy - Vulva (FACT-V) High score correlates to better quality of life. This survey uses a 5-point Likert type scale. Minimum score: 0 Maximum score: 184
Measured: Baseline (enrollment), End of Study (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study start26 Mar 2017
- Primary completion11 Aug 2022
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vulvar Intraepithelial Neoplasia (VIN)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Instruments
- Responsible party
- Sponsor
- Investigators
- Saketh Guntupalli, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02875561
- Sponsor's protocol ID
- 16-0701.cc
- Status last verified
- Oct 2023
- First submitted
- 18 Aug 2016
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
- ClinicalTrials.gov ID
- NCT02875561
- Acronym / sponsor ID
- 16-0701.cc
- Conditions
- Vulvar Intraepithelial Neoplasia (VIN)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Stryker Instruments
- Study start
- 26 Mar 2017 (actual)
- Primary completion
- 11 Aug 2022 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 23 Aug 2016 (estimated)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspiration.
Detailed description
Incidence of Vulvar Intraepithelial Neoplasia (VIN) is increasing among women and there still lacks a standard of care for optimal treatment. Current treatment options aim to treat the symptoms associated with VIN and result in a high recurrence rate. Due to the high reoccurrence rate and the nature of the current treatments, a more effective treatment option is warranted. An effective treatment that targets only the diseased areas could potentially decrease recurrence rates. Additionally, a more conservative treatment modality could contribute to reduced risks of scarring, discomfort, and psychosocial and sexual distraught. The researchers hypothesize that treatment for VIN with ultrasonic aspiration will have a 60% reduction in recurrence rates over 12 months as compared to CO2 laser aspiration.
This study will employ a randomized controlled trial (RCT) design. This is a phase III study to determine the effectiveness of a more targeted treatment therapy for VIN (comparing ultrasonic aspiration versus CO2 laser ablation). Potential participants will be identified through the gynecological clinical practices following diagnosis of high grade VIN and will be randomized (1:1) to one of the treatment therapies. Randomization will be stratified for multi-focal disease and Human Papillomavirus (HPV) status. Both the Sonopet Ultrasonic Aspirator and the CO2 laser ablation devices are FDA approved devices for the treatment of vulvar dysplasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sonopet Ultrasonic Aspirator | Active comparator | Device: Sonopet Ultrasonic AspiratorTreatment of VIN dysplasia with sonopet ultrasonic aspirator: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation |
| CO2 Laser Ablation | Experimental | Device: CO2 Laser AblationTreatment of VIN dysplasia with CO2 Laser Ablation: to evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women 18-89 years old
- Women diagnosed with high-grade VIN (diagnosed by pathology)
- Women referred for vulva sparing treatment for dysplasia
- Women available for follow-up of treatment for 12 months
Key exclusion criteria (5 listed)
- Women who are pregnant
- Women with low-grade VIN dysplasia (diagnosed by pathology)
- Women with vaginal intraepithelial neoplasia(VAIN)
- Women requiring vulvectomy for treatment
- Women unable to provide informed consent
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 |
|---|---|---|
| Sonopet Ultrasonic AspiratorTo evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation | Device | Sonopet Ultrasonic Aspirator |
| CO2 Laser AblationTo evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation | Device | CO2 Laser Ablation |
Primary outcome
Number of Participants With Recurrence of Dysplasia
Time frame: 12 months
Number of participants with recurrence of dysplasia time point 12 months
3 secondary outcomes
Number of Participants With Scarring
Time frame: 6 weeks
Changes in Sexual Function
Time frame: Baseline (enrollment), 12 months
Changes in Mental and Physical Wellness
Time frame: Baseline (enrollment), End of Study (12 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Vulvar Intraepithelial Neoplasia (VIN)
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
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Needlefree Lidocaine Application for Vulvar Biopsies
Vulvar Cancers, Vulva Neoplasm
RecruitingObservational study
InAdvance: Surveillance, Prevention, and Interception in a Population at Risk for Cancer
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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.
Saketh Guntupalli, MD principal investigator
University of Colorado, Denver
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonopet Ultrasonic Aspirator and CO2 Laser Ablation in people with Vulvar Intraepithelial Neoplasia (VIN), run by University of Colorado, Denver at 2 sites 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 4 inclusion and 5 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Recurrence of Dysplasia (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.