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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CUSA Excel® | Subjects having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Excel system. |
| |
| CUSA Clarity® | Subject having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Clarity system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CUSA (Cavitronic Ultrasonic Surgical Aspirator) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Site Recurrence | Incidence of Primary Site Recurrence of Vulvar Intraepithelial Neoplasia or condyloma acuminata. | Up to 12 months Postoperatively. |
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Inclusion Criteria:
Exclusion Criteria: Not Applicable
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Patients identified as genetically female at birth.
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Patients identified as genetically female at birth between the ages of 18 and greater (inclusive) at the time they underwent treatment with CUSA for Vulvar Intraepithelial Neoplasia (VIN) or condyloma acuminata between January 2010 and December 2022. Pregnant patients will be included.
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| Name | Affiliation | Role |
|---|---|---|
| DeEtte Vasques, DO | Private Practice, Dallas, Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Cancer and Blood Disorders | Dallas | Texas | 76014 | United States |
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| ID | Term |
|---|---|
| D003218 | Condylomata Acuminata |
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
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| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014860 | Warts |
| D017193 | Skin Diseases, Viral |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |