CompletedNot Applicable

Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study

United States56 participantsStarted 2024-02-23

Plain-language summary

The study is a single arm, retrospective, single-center, post market registry. The purpose of this Registry is to collect data to demonstrate the safety and performance of CUSA® for the treatment of Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

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

Inclusion Criteria: * Subject had been diagnosed with primary or recurrent Vulvar Intraepithelial Neoplasia (VIN) or condyloma acuminata, treated with CUSA and confirmed by a CUSA pathology report. * Subject had post-operative visits completed at the gynecologic oncology practice. * Subject had surgery with CUSA between January 2010 and December 2022. Exclusion Criteria: Not Applicable

What they're measuring

Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata

Timeframe: During Surgery

Trial details

NCT IDNCT06297187

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Vulvar Intraepithelial Neoplasia trials