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

March 4, 2024 updated by: Integra LifeSciences Corporation

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 76014
        • The Center for Cancer and Blood Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients identified as genetically female at birth between the ages of 18 and greater (inclusive) at the time they underwent treatment with CUSA for Vulvar Intraepithelial Neoplasia (VIN) or condyloma acuminata between January 2010 and December 2022. Pregnant patients will be included.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CUSA Excel®
Subjects having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Excel system.
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.
CUSA Clarity®
Subject having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Clarity system.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata
Time Frame: During Surgery
Ability of CUSA to completely remove Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.
During Surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Site Recurrence
Time Frame: Up to 12 months Postoperatively.
Incidence of Primary Site Recurrence of Vulvar Intraepithelial Neoplasia or condyloma acuminata.
Up to 12 months Postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integra LifeSciences Corporation

Investigators

  • Principal Investigator: DeEtte Vasques, DO, Private Practice, Dallas, Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

February 27, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-CUSAWH-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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