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

Integra LifeSciences

Status

Completed

Conditions

Vulvar Intraepithelial Neoplasia

Condylomata Acuminata

Treatments

Device: CUSA (Cavitronic Ultrasonic Surgical Aspirator)

Study type

Observational

Funder types

Industry

Identifiers

NCT06297187

C-CUSAWH-001

Details and patient eligibility

About

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.

Full description

CUSA® Excel/Clarity Ultrasonic Surgical Aspirator System is indicated for use in the following surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable:

Neurosurgery
Gastrointestinal and affiliated organ surgery
Urological surgery
General surgery
Orthopedic surgery
Gynecological surgery
Laparoscopic surgery

This Registry adds data to support the safety and efficacy for a gynecological surgery indication expansion for the use of CUSA in Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.

Information obtained from this retrospective Registry will help inform a potential future prospective study for this indication in a real-world population.

Enrollment

56 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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