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.
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 Type
OBSERVATIONAL
Enrollment
56
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.
The Center for Cancer and Blood Disorders
Dallas, Texas, United States
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.
Time frame: During Surgery
Primary Site Recurrence
Incidence of Primary Site Recurrence of Vulvar Intraepithelial Neoplasia or condyloma acuminata.
Time frame: Up to 12 months Postoperatively.
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