Condylomata Acuminata, Vulvar Intraepithelial Neoplasia
Conditions
Keywords
Gynecologic Oncology, VIN, Vulvar Intraepithelial Neoplasia, Condylomata Acuminata
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.
Interventions
DEVICECUSA (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.
Sponsors
Integra LifeSciences Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Primary Site Recurrence | Up to 12 months Postoperatively. | Incidence of Primary Site Recurrence of Vulvar Intraepithelial Neoplasia or condyloma acuminata. |
Countries
United States
Outcome results
None listed