Condylomata Acuminata Clinical Trial
Official title:
A Retrospective Registry on the Use of CUSA® for the Treatment of Vulvar Intraepithelial Neoplasia (VIN) and Condyloma Acuminata
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. ;
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