A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding

H. Curlin, Laura Cédo Cintron, Ted L. Anderson
In: Journal of Minimally Invasive Gynecology · 2020 · vol. 28(4) , pp. 899–908 · doi:10.1016/j.jmig.2020.08.013 · PMID:32835865 · W3080518871
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This prospective multicenter trial evaluated the Cerene cryoablation device for heavy menstrual bleeding, demonstrating its safety and effectiveness in significantly reducing menstrual blood loss while improving patient quality of life.

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Abstract

Study objectiveTo evaluate the safety and effectiveness of a novel cryoablation device (Cerene Cryotherapy Device, Channel Medsystems, Emeryville, CA) in premenopausal women with heavy menstrual bleeding owing to benign causes.DesignA prospective, multi-center, single-arm, open label, non-randomized study.SettingAt 11 academic and private practices in North America: 8 clinic sites in the United States, and 3 outpatient hospital sites (1 in Mexico and 2 in Canada).PatientsA total of 242 subjects comprise the intent-to-treat population. Subject demographics were similar to other published endometrial ablation studies performed.InterventionsSubjects were treated with a single-use disposable cryoablation device (Cerene) which delivers a 2.5-minute treatment to the endometrium. Analgesia and local anesthesia were administered per investigator discretion; intravenous sedation was used in only 3% of subjects and no general anesthesia was used.Measurements and main resultsThere were no device or procedure-related serious adverse events, nor unanticipated adverse device effects. Cerene cryoablation was effective in reducing menstrual blood loss, which was measured by pictorial blood loss assessment chart (PBLAC) score. Mean score dropped from 360.6 at pretreatment (±332.1) to 51 at 12 months posttreatment (±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 visualized in 220 subjects. Quality of life improved with 90% of reporting subjects indicating satisfied or very satisfied at month 12.ConclusionThis study demonstrated that Cerene cryoablation is safe and effective, offering the benefits of reduced menstrual blood loss with limited use of pain medication, high patient tolerability, quality of life improvement, and preserved access to the uterine cavity.

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