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

NCT06297187 — Completed, 56 participants, Integra LifeSciences Corporation
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A Retrospective Registry on the Use of CUSA® for the Treatment of Vulvar Intraepithelial Neoplasia (VIN) and Condyloma Acuminata

RegistryNCT06297187
StatusCompleted
Study typeObservational
Enrollment56 (Actual)
SponsorIntegra LifeSciences Corporation (Industry)
ConditionsVulvar Intraepithelial Neoplasia, Condylomata Acuminata
InterventionsCUSA (Cavitronic Ultrasonic Surgical Aspirator) (Device)
Datesstart 2024-02-23, primary completion 2024-07-31, completion 2024-08-31, first posted 2024-03-07, last updated 2024-09-19
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Vulvar Intraepithelial Neoplasia All trials for Condylomata Acuminata All trials of CUSA (Cavitronic Ultrasonic Surgical Aspirator)

-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.

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+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.

+Arms and interventions

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

+Outcome measures

Primary outcomes

  • 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 outcomes

  • Primary Site Recurrence [Up to 12 months Postoperatively.]: Incidence of Primary Site Recurrence of Vulvar Intraepithelial Neoplasia or condyloma acuminata.

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
The Center for Cancer and Blood DisordersDallas, TexasUnited States

+Investigators