Clinical trial · Observational
Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study
A Retrospective Registry on the Use of CUSA® for the Treatment of Vulvar Intraepithelial Neoplasia (VIN) and Condyloma Acuminata
NCT06297187CI-TRIAL-00080686completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Condylomata Acuminata | — | UNRESOLVED | — |
| Vulvar Intraepithelial Neoplasia | Vulvar Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CUSA (Cavitronic Ultrasonic Surgical Aspirator) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- CUSA Excel®
- description
- Subjects having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Excel system.
- interventionNames
- Device: CUSA (Cavitronic Ultrasonic Surgical Aspirator)
- label
- CUSA Clarity®
- description
- Subject having had treatment for Vulvar Intraepithelial Neoplasia (VIN) and/or condyloma acuminata using CUSA® Clarity system.
- interventionNames
- Device: CUSA (Cavitronic Ultrasonic Surgical Aspirator)
Primary outcomes (1)
- measure
- Proportion of Subjects with Complete Removal of Vulvar Intraepithelial Neoplasia and condyloma acuminata
- timeFrame
- During Surgery
- description
- Ability of CUSA to completely remove Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject had been diagnosed with primary or recurrent Vulvar Intraepithelial Neoplasia (VIN) or condyloma acuminata, treated with CUSA and confirmed by a CUSA pathology report. * Subject had post-operative visits completed at the gynecologic oncology practice. * Subject had surgery with CUSA between January 2010 and December 2022. Exclusion Criteria: Not Applicable
References
Publications (0)
Data not yet available
No reference posted for this study.