Clinical Outcomes
Cerene® Cryotherapy is clinically proven to provide a safe and effective in-office endometrial cryoablation treatment.

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 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
High Post-Treatment Satisfaction
90%
had quality of life improvement
90%
were satisfied with Cerene
95%
would recommend Cerene to family and friends†††
Preserved Cavity Access 1 Year Post-Treatment
99%
hysteroscopic uterine cavity access
91%
uterine cavity visualization
96%
ability to evaluate visualized cavities for pathologic change
Publications and Abstracts

Publications

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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Important Safety Information

Cerene® Cryotherapy Device is indicated to ablate the endometrial lining of the uterus in premenopausal women with heavy menstrual bleeding due to benign causes for whom childbearing is complete. Pregnancy following the Cerene procedure can be dangerous; therefore, contraception must be used until menopause. The Cerene procedure is not for those who have or suspect uterine cancer; have an active genital, urinary or pelvic infection; or an IUD. As with all surgical procedures, there are risks and considerations associated with the use of the Cerene Cryotherapy Device. Temporary side effects may include cramping, nausea, vomiting, vaginal discharge and spotting. For detailed benefit and risk information, consult the Cerene Instructions for use (IFU) or your healthcare professional. Learn More