N/A
N=47
Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
Vulvar Intraepithelial Neoplasia (VIN)
Bottom Line
View on ClinicalTrials.gov: NCT02875561 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcome: Primary: Number of Participants With Recurrence of Dysplasia — 5; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sonopet Ultrasonic Aspirator (Device); CO2 Laser Ablation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Colorado, Denver
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Recurrence of Dysplasia |
5; 8 | — |
| SECONDARY Number of Participants With Scarring |
6; 12 | — |
| SECONDARY Changes in Sexual Function |
14.9; 10.9; 10.3; 19.8 | — |
| SECONDARY Changes in Mental and Physical Wellness |
155.6; 145; 147; 156.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02875561). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.