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NCT06297187 · ClinicalTrials.gov registry record
Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study
A clinical trial of Condylomata Acuminata and Vulvar Intraepithelial Neoplasia, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- 56
- Enrollment target
- 1
- Study location
NCT06297187: Completed study of Condylomata Acuminata and Vulvar Intraepithelial Neoplasia, sponsored by Integra LifeSciences Corporation.
NCT06297187 is a study of Condylomata Acuminata and Vulvar Intraepithelial Neoplasia that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 56 participants, below the 162-participant average among 3 other Condylomata Acuminata trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06297187, a study of Condylomata Acuminata and Vulvar Intraepithelial Neoplasia, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- 56 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Ability of CUSA to completely remove Vulvar Intraepithelial Neoplasia (VIN) and condyloma acuminata.
Conditions Studied
Interventions
- DEVICE CUSA (Cavitronic Ultrasonic Surgical Aspirator)
Study Locations (1)
Texas
- The Center for Cancer and Blood Disorders - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2024-02-23 |
| Est. Completion | 2024-08-31 |
What the finished NCT06297187 record still lists
NCT06297187 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 162-participant average among 3 other Condylomata Acuminata trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with Condylomata Acuminata appearing as the primary indexed condition, and to 1 intervention - of which CUSA (Cavitronic Ultrasonic Surgical Aspirator) is the first listed.
NCT06297187 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06297187 about?
NCT06297187 is a clinical study titled "Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study". 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.
What is the current status of trial NCT06297187?
This trial is currently completed. The enrollment target is 56 participants. The study started on 2024-02-23. Estimated completion is 2024-08-31.
What conditions does trial NCT06297187 study?
This clinical trial studies the following conditions: Condylomata Acuminata, Vulvar Intraepithelial Neoplasia.
What interventions are being tested in trial NCT06297187?
The interventions under investigation include: CUSA (Cavitronic Ultrasonic Surgical Aspirator) (DEVICE).
Who is sponsoring clinical trial NCT06297187?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06297187 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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