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NCT06297187 Clinical Trial

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

Condylomata Acuminata Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06297187
Other study ID # C-CUSAWH-001
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 23, 2024
Est. completion date August 2024

Study information
Verified date March 2024
Source Integra LifeSciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 75
Est. completion date August 2024
Est. primary completion date July 2024
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States The Center for Cancer and Blood Disorders Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata Ability of CUSA to completely remove Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata. During Surgery
Secondary Primary Site Recurrence Incidence of Primary Site Recurrence of Vulvar Intraepithelial Neoplasia or condyloma acuminata. Up to 12 months Postoperatively.
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