Clinical trial NCT02875561: Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
Official title: A Randomized Controlled Trial of Ultrasonic Aspiration Versus CO2 Laser Ablation for the Treatment of Vulvar Intraepithelial Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvar Intraepithelial Neoplasia (VIN)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Stryker Instruments
First posted: 2016-08-23
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Recurrence of Dysplasia
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Scarring
timeFrame: 6 weeks
measure: Changes in Sexual Function
timeFrame: Baseline (enrollment), 12 months
measure: Changes in Mental and Physical Wellness
timeFrame: Baseline (enrollment), End of Study (12 months)
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Norman
country: United States
facility: University of Oklahoma
state: Oklahoma
Study officials:
affiliation: University of Colorado, Denver
name: Saketh Guntupalli, MD
role: PRINCIPAL_INVESTIGATOR
References: