A Retrospective Registry on the Use of CUSA® for the Treatment of Vulvar Intraepithelial Neoplasia (VIN) and Condyloma Acuminata
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata
Study Overview
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.
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Primary Site Recurrence(Up to 12 months Postoperatively.)