Clinical Outcomes
Cerene® Endometrial Cryotherapy is clinically proven to provide a safe and effective treatment for Heavy Menstrual Bleeding and Painful Periods.
In an international, multi-center pivotal clinical study, patients reported significant reduction in bleeding and dysmenorrhea, high satisfaction and improved quality of life. Preservation of the uterine cavity, with minimal intrauterine adhesions, for possible future evaluation was also demonstrated at 12 months post-treatment.
The study enrolled 242 patients and reported outcomes at 12, 24 and 36 month endpoints with consistent results. 77% of patients successfully met the primary effectiveness endpoint (per FDA benchmark) of bleeding reduction from a PBLAC (Pictorial Blood Loss Assessment Chart) score of 150+ to ≤ 75 at 12 months. There were no serious adverse events related to the device or treatment.
Effective Treatment
90% had normal, light or no periods†
86% had reduction in dysmenorrhea‡
3% hysterectomy for HMB over 3 years
Well-Tolerated Treatment
92% said their pain level was at or below the acceptable median pain score during treatment
2 out of 10 median pain score during treatment
0 out of 10 median pain score day one post procedure
Preserved Cavity Access 1 Year Post-Treatment
91% uterine cavity visualization
96% ability to evaluate visualized cavities for pathologic change
High Post-Treatment Satisfaction
90% had little to no limitations in their activities after Cerene†
90% were satisfied with Cerene†
95% would recommend Cerene to family and friends†††
† Patient-reported data are 1 year after treatment with durable results at 3 years.
‡ Improvement reported one year after treatment for patients reporting severe/very severe period pain.
††† Patient-reported data include definitely and consider recommending Cerene and are 1 year after treatment with durable results at 3 years.
Publications and Abstracts
Publications
Smith, Shannon and Reilly, Gerard, Modernizing Treatment for Heavy Menstrual Bleeding: The Smart Evolution Into Cryoablation, Contemporary OB/GYN, May 2023: https://www.contemporaryobgyn.net/view/modernizing-treatment-for-heavy-menstrual-bleeding-the-smart-evolution-into-cryoablation.
Curlin, Howard L, et al. “A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the CERENE Device to Treat Heavy Menstrual Bleeding.” Journal of Minimally Invasive Gynecology, vol. 28, no. 4, 2021, pp. 899–908., https://doi.org/10.1016/j.jmig.2020.08.013.
Curlin, Howard, et al. “Hysteroscopic Access and Uterine Cavity Evaluation 12 Months Post-Endometrial Ablation with the CERENE® Cryotherapy Device.” Journal of Minimally Invasive Gynecology, 2021, https://doi.org/10.1016/j.jmig.2021.11.016.
2021 AAGL Abstracts
Curlin, H.L., and T.L. Anderson. “The CERENE Cryoablation Device for the Treatment of Heavy Menstrual Bleeding: 36-Month Outcomes from the Clarity Study.” Journal of Minimally Invasive Gynecology, vol. 28, no. 11, 2021, https://doi.org/10.1016/j.jmig.2021.09.416.
2019 AAGL Abstracts
Cholkeri-Singh, A, and JG Garza Leal. “Hysteroscopic Access and Uterine Cavity Evaluation 12 Months Post-Endometrial Ablation with the CERENE Cryotherapy Device.” Journal of Minimally Invasive Gynecology, vol. 26, no. 7, 2019, https://doi.org/10.1016/j.jmig.2019.09.537.
Curlin, HL, and TL Anderson. “A Clinical Study to Evaluate the Safety and Effectiveness of the CERENE Device to Treat Heavy Menstrual Bleeding (Clarity Study).” Journal of Minimally Invasive Gynecology, vol. 26, no. 7, 2019, https://doi.org/10.1016/j.jmig.2019.09.598.
Fortin, CA. “Pain Management and Subject Comfort during an Endometrial Ablation Treatment with the CERENE Cryotherapy Device.” Journal of Minimally Invasive Gynecology, vol. 26, no. 7, 2019, https://doi.org/10.1016/j.jmig.2019.09.675.
Pietzsch, JB, et al. “2480 Budget Impact of Changes in Site-of-Service and Modality of Endometrial Ablation for Severe Menstrual Bleeding for United States Payers and Providers.” Journal of Minimally Invasive Gynecology, vol. 26, no. 7, 2019, https://doi.org/10.1016/j.jmig.2019.09.241.
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