289: Initial Safety of Her Option® Endometrial Cryoablation using Extended Treatment Regimens in an Out-patient Setting

Abstract

To assess safety and efficacy of extended treatment regimens under real-time ultrasound guidance using the Her Option cryotherapy in an out-patient setting. Multi-center prospective clinical trial. Seven US sites, 32 subjects treated to date in an outpatient setting using the Her Option System. Thirty-two subjects, age 39.6 +/− 4.46, documented menorrhagia due to benign causes, uterine sound measurements 4–10 cm and myomas <3 cm. Extended treatment using uterine dimensions to plan probe placement and freeze length were performed. Subjects underwent 2–4 freezes of up to 10 minutes, maintaining a minimum distance of 2mm from the serosa on ultrasound. Subjects went home approximately 1 hour post-treatment, and returned in 2 weeks for follow-up. All subjects tolerated treatment well with minimal sedation. Eight subjects experienced adverse events during the acute follow-up period, consisting of UTI (3), pelvic pain/discomfort (3), back/hip pain (2), rash (1) and urinary burning (1). Events were predominantly mild, short in duration and required little to no intervention. Extended treatment regimens are tolerated well in an out-patient setting. Preliminary data suggest real-time ultrasound monitoring of cryozone advancement is adequate to maintain the safety while providing increased tissue coverage.