NCT06297187

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

A Retrospective Registry on the Use of CUSA® for the Treatment of Vulvar Intraepithelial Neoplasia (VIN) and Condyloma Acuminata

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: Integra LifeSciences Corporation · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Vulvar Intraepithelial Neoplasia
• Condylomata Acuminata

Interventions

Type	Name	Description
DEVICE	CUSA (Cavitronic Ultrasonic Surgical Aspirator)	CUSA® Excel and CUSA® Clarity Ultrasonic Surgical Aspirator Systems are indicated for use in the surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable.

Timeline

• Start date: 2024-02-23
• Primary completion: 2024-07-31
• Completion: 2024-08-31
• First posted: 2024-03-07
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study