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

Vulvar Intraepithelial Neoplasia (VIN) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875561
• Other study ID #: 16-0701.cc
• Status: Completed
• Phase: N/A
• Start date: March 26, 2017
• Est. completion date: April 20, 2023

Study information

• Verified date: October 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 20, 2023
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma in Situ
• Neoplasms
• Vulvar Intraepithelial Neoplasia (VIN)

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Colorado Denver	Aurora	Colorado
United States	University of Oklahoma	Norman	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Stryker Instruments

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Recurrence of Dysplasia	Number of participants with recurrence of dysplasia time point 12 months	12 months
Secondary	Number of Participants With Scarring	Physical evaluation for scarring	6 weeks
Secondary	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
Secondary	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)