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Completed

NCT Number: NCT06297187

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

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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Key information

Conditions

Vulvar Intraepithelial Neoplasia Communicable Diseases Condylomata Acuminata DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

The Center for Cancer and Blood Disorders

Dallas, Texas, 76014, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Primary Site Recurrence

    Time frame: Up to 12 months Postoperatively.

    Incidence of Primary Site Recurrence of Vulvar Intraepithelial Neoplasia or condyloma acuminata.

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 7, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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