Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06297187
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2024-02-27
Brief Title:
Cavitronic Ultrasonic Surgical Aspiration CUSA Womens Health Study
Sponsor:
Integra LifeSciences Corporation
Organization:
Integra LifeSciences Corporation
Study Overview
Official Title:
A Retrospective Registry on the Use of CUSA for the Treatment of Vulvar Intraepithelial Neoplasia VIN and Condyloma Acuminata
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ExcelClarity 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None