Trial Outcomes & Findings for Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia (NCT NCT02875561)
NCT ID: NCT02875561
Last Updated: 2023-11-18
Results Overview
Number of participants with recurrence of dysplasia time point 12 months
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
12 months
Results posted on
2023-11-18
Participant Flow
Participant milestones
| Measure |
Sonopet Ultrasonic Aspirator
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
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
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
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
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
28
|
|
Overall Study
COMPLETED
|
19
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
Baseline characteristics by cohort
| Measure |
Sonopet Ultrasonic Aspirator
n=19 Participants
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
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
n=28 Participants
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
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
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber of participants with recurrence of dysplasia time point 12 months
Outcome measures
| Measure |
Sonopet Ultrasonic Aspirator
n=19 Participants
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
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
n=28 Participants
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
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
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6 weeksPhysical evaluation for scarring
Outcome measures
| Measure |
Sonopet Ultrasonic Aspirator
n=19 Participants
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
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
n=28 Participants
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
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 Scarring
|
6 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline (enrollment), 12 monthsPopulation: all surveys at all timepoints were optional. Some participants completed all surveys, some completed only baseline surveys and some only completed end of study surveys. This is why the population varies between timepoints.
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.
Outcome measures
| Measure |
Sonopet Ultrasonic Aspirator
n=15 Participants
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
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
n=24 Participants
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
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
|
|---|---|---|
|
Changes in Sexual Function
Baseline
|
14.9 score on a scale
Standard Deviation 12.3
|
10.9 score on a scale
Standard Deviation 9.5
|
|
Changes in Sexual Function
End of Study
|
10.3 score on a scale
Standard Deviation 11.3
|
19.8 score on a scale
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: Baseline (enrollment), End of Study (12 months)Population: all surveys at all timepoints were optional. Some participants completed all surveys, some completed only baseline surveys and some only completed end of study surveys. This is why the population varies between timepoints.
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
Outcome measures
| Measure |
Sonopet Ultrasonic Aspirator
n=16 Participants
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
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
n=25 Participants
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
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
|
|---|---|---|
|
Changes in Mental and Physical Wellness
Baseline
|
155.6 score on a scale
Standard Deviation 29.8
|
145 score on a scale
Standard Deviation 29.1
|
|
Changes in Mental and Physical Wellness
End of Study
|
147 score on a scale
Standard Deviation 26.4
|
156.5 score on a scale
Standard Deviation 20.9
|
Adverse Events
Sonopet Ultrasonic Aspirator
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
CO2 Laser Ablation
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sonopet Ultrasonic Aspirator
n=19 participants at risk
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
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
n=28 participants at risk
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
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
|
|---|---|---|
|
General disorders
discomfort
|
5.3%
1/19 • Number of events 1 • 12 months
|
7.1%
2/28 • Number of events 2 • 12 months
|
|
General disorders
pain
|
21.1%
4/19 • Number of events 4 • 12 months
|
14.3%
4/28 • Number of events 4 • 12 months
|
|
Reproductive system and breast disorders
vaginal bleeding
|
0.00%
0/19 • 12 months
|
10.7%
3/28 • Number of events 3 • 12 months
|
|
Reproductive system and breast disorders
discharge
|
15.8%
3/19 • Number of events 3 • 12 months
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Skin and subcutaneous tissue disorders
anal pruritus
|
5.3%
1/19 • Number of events 1 • 12 months
|
0.00%
0/28 • 12 months
|
|
General disorders
tenderness
|
5.3%
1/19 • Number of events 1 • 12 months
|
7.1%
2/28 • Number of events 2 • 12 months
|
|
Skin and subcutaneous tissue disorders
cellulitis
|
0.00%
0/19 • 12 months
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Infections and infestations
infection
|
0.00%
0/19 • 12 months
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
General disorders
irritation
|
5.3%
1/19 • Number of events 1 • 12 months
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Infections and infestations
yeast infection
|
0.00%
0/19 • 12 months
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
General disorders
itching
|
5.3%
1/19 • Number of events 1 • 12 months
|
3.6%
1/28 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
soreness at site
|
0.00%
0/19 • 12 months
|
3.6%
1/28 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place