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

Active, not recruiting

• Conditions: Vulvar Intraepithelial Neoplasia; Condylomata Acuminata
• Interventions: Device: CUSA (Cavitronic Ultrasonic Surgical Aspirator)

• Registration Number: NCT06297187
• Lead Sponsor: Integra LifeSciences Corporation

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2024-02-23
• Study First Submitted: 2024-02-27
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-04
• Last Update Submitted: 2024-03-04
• Study First Posted: 2024-03-07
• Last Update Posted: 2024-03-07
• Primary Completion: 2024-07
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CUSA Excel®	CUSA (Cavitronic Ultrasonic Surgical Aspirator)	Subjects having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Excel system.
CUSA Clarity®	CUSA (Cavitronic Ultrasonic Surgical Aspirator)	Subject having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Clarity system.

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata	During Surgery	Ability of CUSA to completely remove Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.

Secondary Outcome Measures

Name	Time	Method
Primary Site Recurrence	Up to 12 months Postoperatively.	Incidence of Primary Site Recurrence of Vulvar Intraepithelial Neoplasia or condyloma acuminata.

Trial Locations

Locations (1)

The Center for Cancer and Blood Disorders; 🇺🇸 Dallas, Texas, United States