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

Primary Objective

The primary objective of this study is to evaluate the incidence of vulva dysplasia recurrence within 12 months of treatment with CO2 laser ablation or ultrasonic aspiration. Women referred for treatment following diagnosis of VIN II/III will be randomized to receive CO2 laser ablation (typical treatment for these cases) or ultrasonic aspiration (approved treatment providing a more targeted technique). Secondary objectives will examine incidences of pain, scarring, and sexual and psychosocial distraught following treatment for high-grade dysplasia.

Study category: Surgical and Wound Care

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Details
Age

Adult

Eligibility

Inclusion criteria: ? Women 18-89 years old ? Diagnosed with VIN II/III (diagnosed by pathology) ? Referred for vulva sparing treatment for dysplasia ? Available for follow-up of treatment for 12 months Exclusion criteria: ? Women who are pregnant ? Women with VIN I dysplasia (diagnosed by pathology) ? Women with vaginal intraepithelial neoplasia (VAIN) ? Women requiring vulvectomy for treatment ? Women unable to provide informed consent

Phase

III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.

Type of Study

Treatment

Locations

Denver Health Medical Center
University of Colorado Hospital
University of Oklahoma

Principal Investigator
Saketh Guntupalli,  MD

Saketh Guntupalli, MD

Study ID

Protocol Number: 16-0701

ClinicalTrials.gov: NCT02875561

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