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

Abstract

Study objective: To evaluate whether physical access and the ability to systematically assess the postablation uterine cavity were preserved at 12 months after endometrial ablation with the Cerene cryotherapy device (ChannelMedsystems, Emeryville, CA).

Design: A prospective, multicenter, 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: A total of 230 (of 242) subjects continued in the study at the Month 12 visit after ablation. Two hundred twenty-three subjects were available for a diagnostic hysteroscopic evaluation.

Interventions: Subjects who had previously been treated with a 2.5-minute cryoablation of the endometrium utilizing the Cerene device underwent a diagnostic hysteroscopy at the Month 12 follow-up visit.

Measurements and main results: The uterine cavity was accessible in 220 of 223 subjects (98.7%) and not accessible in 3 (1.3%) because of pain (n = 2) and cervical stenosis (n = 1). Visualization of the uterine cavity was possible in 204 of 220 subjects (92.7%) with one or both tubal ostia identified in 89.2% (182 of 204) of subjects. Both tubal ostia were visible in 160 of 204 subjects (78.4%) and one ostium in 22 of 204 subjects (10.8%). The cavity was not visualized in the remaining 16 of 220 subjects (7.2%) because of intrauterine adhesions (n = 14), technical difficulties (n = 1), or menstruation (n = 1). In 95.6% (195 of 204) of subjects where the cavity was visualized, the hysteroscopic view was judged adequate to evaluate the uterine cavity for pathologic change. No significant complications occurred during the hysteroscopic evaluations.

Conclusion: This is the largest study to date conducted to hysteroscopically evaluate the postablation uterine cavity. Uterine cavity assessment with in-office hysteroscopy 1 year after the use of the Cerene cryotherapy device is attainable, enabling both diagnostic and therapeutic procedures within the endometrial cavity.

Trial registration: ClinicalTrials.gov NCT02842736.

Keywords: Abnormal uterine bleeding; Adhesions; Cryoablation; Endometrial ablation; Hysteroscopy.