Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study
NCT ID: NCT06297187
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
56 participants
OBSERVATIONAL
2024-02-23
2024-08-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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CUSA Excel®
Subjects having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Excel system.
CUSA (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.
CUSA Clarity®
Subject having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Clarity system.
CUSA (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.
Interventions
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CUSA (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.
Eligibility Criteria
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Inclusion Criteria
* Subject had post-operative visits completed at the gynecologic oncology practice.
* Subject had surgery with CUSA between January 2010 and December 2022.
18 Years
FEMALE
No
Sponsors
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Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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DeEtte Vasques, DO
Role: PRINCIPAL_INVESTIGATOR
Private Practice, Dallas, Texas
Locations
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The Center for Cancer and Blood Disorders
Dallas, Texas, United States
Countries
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Other Identifiers
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C-CUSAWH-001
Identifier Type: -
Identifier Source: org_study_id
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