A Clinical Study to Evaluate the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding (Clarity Study)

Abstract

Study Objective To evaluate the safety and effectiveness of a novel cryoablation device (Cerene Cryotherapy Device, Channel Medsystems, Emeryville, CA) in premenopausal women with heavy menstrual bleeding due to benign causes. Design A prospective, multi-center, single-arm, open-label, non-randomized study Setting At 11 academic and private practices in North America: 8 clinic sites in the US, and 3 outpatient hospital sites (1 in Mexico and 2 in Canada). Patients or Participants 242 subjects comprise the Intent-to-Treat (ITT) population. Subject demographics were similar to other published endometrial ablation studies performed. Interventions Subjects were treated with the Cerene Device, a single-use disposable device requiring no capital equipment, which delivers a 2.5-minute cryoablation of the endometrium. Analgesia and local anesthesia were administered per investigator discretion; IV sedation was used in only 3% of subjects and no general anesthesia was used. Measurements and Main Results There were no device- or procedure-related serious adverse events, nor unanticipated adverse device effects. The Cerene Device was effective in reducing menstrual blood loss measured by pictorial blood loss assessment chart (PBLAC) score. Mean score dropped from 360.6 pretreatment (± 332.1; range 150-4506) to 51 at 12 months post treatment (±64.1), with 81% of 230 evaluable subjects reporting a PBLAC score of ≤ 75 and 85% of evaluable subjects reporting a PBLAC score of ≤ 100. The median pain rating was ≤ 2 (mild) throughout the treatment. Of 223 subjects that underwent hysteroscopic evaluation at 12 months, the uterine cavity was accessible and visualized in 220 subjects. Quality of life improved with 90% of reporting subjects indicating satisfied or very satisfied at Month 12. Conclusion The study demonstrated that the Cerene Device is safe and effective and provides the benefits of reduced menstrual blood loss, limited use of pain medication, high patient tolerability, quality of life improvement, and preserved access to the uterine cavity.