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.
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
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.
Denver Health and Hospital Authority
Regional West Medical Center
University of Colorado Hospital
University of Oklahoma
Saketh Guntupalli, MD
Protocol Number: 16-0701
More information available at ClinicalTrials.gov: NCT02875561
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