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

NCT06297187 | Completed FDA Device

• 1 other identifier: C-CUSAWH-001
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vulvar Intraepithelial Neoplasia; Condylomata Acuminata

Keywords

Gynecologic Oncology; VIN; Vulvar Intraepithelial Neoplasia; Condylomata Acuminata

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Primary Site Recurrence

  Up to 12 months Postoperatively.

Study Arms (2)

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 Clarity®

Subject having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Clarity system.

Device: CUSA (Cavitronic Ultrasonic Surgical Aspirator)

Interventions

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.

CUSA Clarity®; CUSA Excel®

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients identified as genetically female at birth.
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead

Study Sites (1)

The Center for Cancer and Blood Disorders

Dallas, Texas, 76014, United States

Location

MeSH Terms

Conditions

Condylomata Acuminata

Condition Hierarchy (Ancestors)

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

Study Officials

• DeEtte Vasques, DO

  Private Practice, Dallas, Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 7, 2024
• Study Start: February 23, 2024
• Primary Completion: July 31, 2024
• Study Completion: August 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)