N/A
Completed N=47
Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
Vulvar Intraepithelial Neoplasia (VIN)
Source: ClinicalTrials.gov NCT02875561 ↗
Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Nov 2023
Primary outcomePrimary: Number of Participants With Recurrence of Dysplasia — 5; 8 Participants
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.
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 | — |
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. Informational only — not medical advice.