Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia

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

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 Overview

• Status: Completed
• Conditions: Vulvar Intraepithelial Neoplasia (VIN)
• Intervention / Treatment: Device: Sonopet Ultrasonic Aspirator; Device: CO2 Laser Ablation

Detailed Description

Incidence of Vulvar Intraepithelial Neoplasia (VIN) is increasing among women and there still lacks a standard of care for optimal treatment. Current treatment options aim to treat the symptoms associated with VIN and result in a high recurrence rate. Due to the high reoccurrence rate and the nature of the current treatments, a more effective treatment option is warranted. An effective treatment that targets only the diseased areas could potentially decrease recurrence rates. Additionally, a more conservative treatment modality could contribute to reduced risks of scarring, discomfort, and psychosocial and sexual distraught. The researchers hypothesize that treatment for VIN with ultrasonic aspiration will have a 60% reduction in recurrence rates over 12 months as compared to CO2 laser aspiration.

This study will employ a randomized controlled trial (RCT) design. This is a phase III study to determine the effectiveness of a more targeted treatment therapy for VIN (comparing ultrasonic aspiration versus CO2 laser ablation). Potential participants will be identified through the gynecological clinical practices following diagnosis of high grade VIN and will be randomized (1:1) to one of the treatment therapies. Randomization will be stratified for multi-focal disease and Human Papillomavirus (HPV) status. Both the Sonopet Ultrasonic Aspirator and the CO2 laser ablation devices are FDA approved devices for the treatment of vulvar dysplasia.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver
  • Oklahoma
    • Norman, Oklahoma, United States, 73019
      • University of Oklahoma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women 18-89 years old
• Women diagnosed with high-grade VIN (diagnosed by pathology)
• Women referred for vulva sparing treatment for dysplasia
• Women available for follow-up of treatment for 12 months

Exclusion Criteria:

• Women who are pregnant
• Women with low-grade VIN dysplasia (diagnosed by pathology)
• Women with vaginal intraepithelial neoplasia(VAIN)
• Women requiring vulvectomy for treatment
• Women unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sonopet Ultrasonic Aspirator; Treatment of VIN dysplasia with sonopet ultrasonic aspirator: 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	Device: Sonopet Ultrasonic Aspirator; 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
Experimental: CO2 Laser Ablation; Treatment of VIN dysplasia with CO2 Laser Ablation: 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	Device: CO2 Laser Ablation; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Recurrence of Dysplasia	Number of participants with recurrence of dysplasia time point 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Scarring	Physical evaluation for scarring	6 weeks
Changes in Sexual Function	Evaluated by Female Sexual Function Index Scale Title: Female Sexual Function Index (FSFI) Minimum value: 2.0 Maximum value: 36.0 a score of 0 in any domain correlates to no sexual activity. a score of 0 in any domain correlates to no sexual activity in that domain alone, and is not indicative of the total score. Lower scores indicate worse sexual function.	Baseline (enrollment), 12 months
Changes in Mental and Physical Wellness	Evaluated by Functional Assessment of Cancer Therapy - Vulva (FACT-V) health survey for vulva disease Scale Title: Functional Assessment of Cancer Therapy - Vulva (FACT-V) High score correlates to better quality of life. This survey uses a 5-point Likert type scale. Minimum score: 0 Maximum score: 184	Baseline (enrollment), End of Study (12 months)

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Stryker Instruments
• Investigators: Principal Investigator: Saketh Guntupalli, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2017
• Primary Completion (Actual): August 11, 2022
• Study Completion (Actual): April 20, 2023

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimated): August 23, 2016

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms; Carcinoma in Situ
• Other Study ID Numbers: 16-0701.cc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes