Abstract
<h3>Study Objective</h3> To evaluate the safety and effectiveness of a novel cryoablation device (<i>Cerene Cryotherapy Device, Channel Medsystems, Berkeley, CA)</i> in premenopausal women with heavy menstrual bleeding (HMB) due to benign causes. <h3>Design</h3> A prospective, multi-center, single-arm, open-label study. <h3>Setting</h3> 8 sites in the USA, 1 in Mexico, 2 in Canada. <h3>Patients or Participants</h3> 242 Intent-to-Treat women, 25 to 50 years of age, with HMB, uterine sound ≤10 cm, and endometrial cavity between 2.5 to 6.5 cm. <h3>Interventions</h3> The Cerene single-use disposable device, delivered a 2.5-minute cryoablation of the endometrium. Analgesia and local anesthesia were administered per investigator discretion: 97% of subjects received a paracervical block with or without oral medications, 3% IV sedation, and none received general anesthesia. 180 USA treatments were performed in the physician office setting and none in the operating room. Subjects were evaluated through Month 12 and long term at Month 24 and 36. <h3>Measurements and Main Results</h3> 201 women were evaluated at Month 36. 88.6% (178/201) reported amenorrhea, a lighter than normal, or normal period. 91% (182/201) reported no or slight limitations in life activities in their Menorrhagia Impact Quality of Life (QoL) questionnaire. 85% (171/201) reported premenstrual symptoms (PMS) at a low frequency (none, rarely, or sometimes) in their PMS Impact QoL Survey. 84.5% (153/181) of subjects who reported level of satisfaction at the final study visit stated that they were satisfied or very satisfied with their treatment outcome. 7% (17/242) underwent a post ablation intervention for menstrual bleeding. <h3>Conclusion</h3> The Cerene endometrial cryoablation device maintains safety and effectiveness for the treatment of HMB through the long-term study visit at 36 months. It is a global endometrial ablation technique that can be performed consistently in the office setting requiring minimal anesthesia or analgesia.
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