Hysteroscopic Access and Uterine Cavity Evaluation 12 Months Post-Endometrial Ablation with the Cerene Cryotherapy Device

Abstract

Study Objective To evaluate if physical access and the ability to systematically assess the post-ablation uterine cavity were preserved at 12 months after endometrial ablation with the Cerene Cryotherapy Device (Channel Medsystems, Emeryville, CA). Design A prospective, multi-center, single-arm study. Setting In the clinic at 8 US sites and outpatient hospital setting at 2 sites in Canada and 1 site in Mexico. Patients or Participants 242 premenopausal women with heavy menstrual bleeding comprise the Intent-to-Treat (ITT) population. At the 12-month post-ablation follow-up, 223 subjects were available for a diagnostic hysteroscopic evaluation. Interventions Subjects in the ITT population were treated with a 2.5-minute cryoablation of the endometrium utilizing the Cerene Device. At the Month 12 follow-up visit, subjects underwent a diagnostic hysteroscopy. Measurements and Main Results The uterine cavity was accessible in 220 of 223 subjects (98.7%) and not accessible in 3 (2.3%) due to pain in 2 and cervical stenosis in 1. Complete visualization of the uterine cavity was possible in 204 subjects (93%) with one or both tubal ostia identified in 89.2% of subjects. Both tubal ostia were visible in 160 subjects (78.4%) and one ostium in 22 subjects (10.8%). The cavity was partially visualized in the remaining 16 subjects (7%) due to intrauterine adhesions (14), technical difficulties (1), or menstruation (1). In 95.6% of subjects, the hysteroscopic view was adequate to evaluate the uterine cavity for pathologic change. No significant complication occurred during the hysteroscopic evaluations. Of the 97 subjects that had a tubal ligation prior to cryoablation, none reported symptoms of post ablation tubal sterilization syndrome or hematometra. Conclusion This is the largest study conducted to hysteroscopically evaluate the post-ablation uterine cavity. Complete uterine cavity assessment with in-office hysteroscopy one year after the use of the Cerene Cryotherapy device is attainable enabling further diagnostic or therapeutic procedures to be performed within the endometrial cavity.