An interventional study of Sonopet Ultrasonic Aspirator and CO2 Laser Ablation in Vulvar Intraepithelial Neoplasia (VIN), sponsored by University of Colorado, Denver. Completed at 2 sites in United States. Open to female participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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.
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.
University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 318 are open to participants now.
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Exclusion Criteria:
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
Device: Sonopet Ultrasonic Aspirator
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
Device: 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
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
Number of Participants With Recurrence of Dysplasia
Number of participants with recurrence of dysplasia time point 12 months
Time frame: 12 months
Number of Participants With Scarring
Physical evaluation for scarring
Time frame: 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.
Time frame: 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
Time frame: Baseline (enrollment), End of Study (12 months)
| Milestone | Sonopet Ultrasonic Aspirator | CO2 Laser Ablation |
|---|---|---|
| Started | 19 | 28 |
| Completed | 19 | 28 |
| Not completed | 0 | 0 |
Number of participants with recurrence of dysplasia time point 12 months
| Participants | Sonopet Ultrasonic Aspirator | CO2 Laser Ablation |
|---|---|---|
| Number of Participants With Recurrence of Dysplasia | 5 | 8 |
Physical evaluation for scarring
| Participants | Sonopet Ultrasonic Aspirator | CO2 Laser Ablation |
|---|---|---|
| Number of Participants With Scarring | 6 | 12 |
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.
| score on a scale | Sonopet Ultrasonic Aspirator | CO2 Laser Ablation |
|---|---|---|
| Baseline | 14.9 ± 12.3 | 10.9 ± 9.5 |
| End of Study | 10.3 ± 11.3 | 19.8 ± 10.1 |
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
| score on a scale | Sonopet Ultrasonic Aspirator | CO2 Laser Ablation |
|---|---|---|
| Baseline | 155.6 ± 29.8 | 145 ± 29.1 |
| End of Study | 147 ± 26.4 | 156.5 ± 20.9 |
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sonopet Ultrasonic Aspirator | 0/19 (0%) | 0/19 (0%) | 12/19 (63.2%) |
| CO2 Laser Ablation | 0/28 (0%) | 0/28 (0%) | 18/28 (64.3%) |
| Event | Sonopet Ultrasonic Aspirator | CO2 Laser Ablation |
|---|---|---|
| painGeneral disorders | 4/19 | 4/28 |
| dischargeReproductive system and breast disorders | 3/19 | 1/28 |
| vaginal bleedingReproductive system and breast disorders | 0/19 | 3/28 |
| discomfortGeneral disorders | 1/19 | 2/28 |
| tendernessGeneral disorders | 1/19 | 2/28 |
| anal pruritusSkin and subcutaneous tissue disorders | 1/19 | 0/28 |
| irritationGeneral disorders | 1/19 | 1/28 |
| itchingGeneral disorders | 1/19 | 1/28 |
| cellulitisSkin and subcutaneous tissue disorders | 0/19 | 1/28 |
| infectionInfections and infestations | 0/19 | 1/28 |
| Age, Categorical(Participants) | Sonopet Ultrasonic Aspirator | CO2 Laser Ablation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 16 | 18 | 34 |
| >=65 years | 3 | 10 | 13 |
| Sex: Female, Male(Participants) | Sonopet Ultrasonic Aspirator | CO2 Laser Ablation | Total |
|---|---|---|---|
| Female | 19 | 28 | 47 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sonopet Ultrasonic Aspirator | CO2 Laser Ablation | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 17 | 27 | 44 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Sonopet Ultrasonic Aspirator | CO2 Laser Ablation | Total |
|---|---|---|---|
| United States | 19 | 28 | 47 |
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Plan to share: No
Ran from Mar 2017 to primary completion in Aug 2022, 64 months.
Results were first posted in Nov 2023, 1 year 3 months after primary completion.
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