CompletedNot Applicable

Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia

United States47 participantsStarted 2017-03-26

Plain-language 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.

Who can participate

Age range18 Years – 89 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With Recurrence of Dysplasia

Timeframe: 12 months

Trial details

NCT IDNCT02875561

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-08-11

Results submitted2023-08-14

View on ClinicalTrials.gov More Vulvar Intraepithelial Neoplasia (VIN) trials