Pain Management and Subject Comfort During an Endometrial Ablation Treatment with the Cerene Cryotherapy Device

Abstract

Study Objective To evaluate the use of medications to manage pain and/or anxiety and the subjects’ level of perioperative pain related to an endometrial ablation treatment with the Cerene Cryotherapy Device (Channel Medsystems, Emeryville, CA). Design A prospective, multi-center, single-arm, open-label, non-randomized study. Setting At 11 academic and private practice settings across North America: 8 sites in the US, 1 site in Mexico, and 2 sites in Canada. Patients or Participants 242 subjects comprise the Intent-to-Treat (ITT) population. Interventions Subjects were treated with the Cerene Device, which delivers a 2.5-minute cryoablation of the endometrium. Analgesia and local anesthesia were administered per investigator discretion. Subjects rated their pain at screening, 5 time points during treatment, and at 3 time points up to 24 hours post-treatment using a numeric rating scale of 0-10. Measurements and Main Results The Cerene treatment was completed with only paracervical block (PCB) in 20 subjects (8.3%), PCB with nonsteroidal anti-inflammatory drugs (NSAIDs) in 48 subjects (19.8%), PCB with oral narcotics and/or anxiolytics in 167 subjects (69%), and IV sedation in 7 subjects (2.9%). No subject received general anesthesia or required airway management. Subjects reported a median pain rating of 2 or less throughout the Cerene treatment. The median pain score was 2 at discharge and 0 at twenty four hours. Conclusion The use of general anesthesia and/or intravenous sedation was markedly less for the Cerene treatment than that reported in clinical studies of other commercially available heat-based non-resectoscopic endometrial ablation devices. The vast majority of subjects tolerated the procedure well with oral NSAIDs, anxiolytics, and/or pain medications. The study demonstrated the natural analgesic effect of cryoablation due to the freezing of pain receptors in the uterus. The Cerene device allows the endometrial ablation treatment of heavy menstrual bleeding to be performed comfortably as an office-based procedure without the support of an anesthesiologist.