CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 47 enrolled
Drug / intervention
Sonopet Ultrasonic Aspirator +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02875561
NCT02875561N/ACompleted
CompareCT.gov

A Randomized Controlled Trial of Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia

University of Colorado, Denver·interventional·Posted Aug 23, 2016·Updated Nov 18, 2023

In Brief

A clinical study evaluating Sonopet Ultrasonic Aspirator and CO2 Laser Ablation for Vulvar Intraepithelial Neoplasia (VIN). Completed, enrolled 47 participants across 2 sites.

Detailed Summary

The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with Carbon Dioxide (CO2) laser ablation or ultrasonic aspiration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvar Intraepithelial Neoplasia (VIN)
CountriesUnited States
CollaboratorsStryker Instruments

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedAug 23, 2016
Enrollment StartMar 26, 2017
Primary CompletionAug 11, 2022
Study CompletionApr 20, 2023
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 9.9 years ago

Interventions

Sonopet Ultrasonic Aspiratordevice

To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation

CO2 Laser Ablationdevice

To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation