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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Vulvar Intraepithelial Neoplasia (VIN)

Treatments: Device: CO2 Laser Ablation; Device: Sonopet Ultrasonic Aspirator

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02875561

16-0701.cc

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: Female

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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47 participants in 2 patient groups

Sonopet Ultrasonic Aspirator

Active Comparator group

Description:

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

Treatment:

Device: Sonopet Ultrasonic Aspirator

CO2 Laser Ablation

Experimental group

Description:

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

Treatment:

Device: CO2 Laser Ablation