How to Maintain Patient Safety During Endometrial Ablation

Endometrial ablation is a well-documented treatment for heavy menstrual bleeding (HMB) – also known as menorrhagia – offering long-term relief for patients grappling with excessive blood loss and dysmenorrhea.¹ Yet, while addressing these symptoms is crucial, safety remains paramount for any OBGYN when considering endometrial ablation techniques.

Although endometrial ablation inherently presents fewer risks than more invasive menorrhagia treatments, such as hysterectomy, it’s essential to understand that no procedure is entirely without risk.² Ablations, while effective, have the potential to affect surrounding structures, including the deep myometrium, bowel, or bladder. In response to these concerns, experts in the medical community should actively assess the safety features of various ablation techniques.  

Endometrial Cryoablation With Cerene^®

The Cerene Cryotherapy Device not only deploys cryothermal energy (in the form of nitrous oxide) into a cavity-conforming liner to ablate the endometrial lining, but also triggers a healing process unique to cryotherapy that results in minimal intrauterine adhesions. The cooling technology freezes the sensory nerves of the uterus, delivering a natural cryoanalgesic effect that reduces the need for general anesthesia or IV sedation for pain management. Cerene is designed with built-in safety features to maintain patient safety throughout the ablation procedure. 

90% of patients are satisfied with Cerene:^†

†Patient-reported data include definitely and consider recommending Cerene and are 1 year after treatment with durable results at 3 years.

How Cerene Promotes Patient Safety

The first step in driving treatment success and safety is selecting the right patient. Not every patient is a suitable candidate for endometrial ablation with the Cerene Device. Gynecologists must ensure their patient is not pregnant or planning future pregnancies, does not have known or suspected uterine cancer or unresolved endometrial hyperplasia, lacks certain anatomic or pathologic conditions that weaken the myometrium, has no history of prior endometrial ablation or resection, is free from active genital or urinary tract infections, does not have an IUD in place, and is not experiencing undiagnosed vaginal bleeding.⁴ 

Once patient eligibility is verified, OBGYNs can move forward with the cryoablation procedure, utilizing Cerene. From start to finish, the Cerene device prioritizes patient safety with a variety of multi-tiered features, including:

• Cavity-conforming liner. Once deployed, the ultra-thin flexible balloon liner gradually opens and covers the entire endometrial surface, accounting for cavity irregularities and individual anatomy differences. This ensures uniform cavity coverage during nitrous oxide administration. Rather than allowing direct contact with the freezing agent, nitrous oxide is deployed into Cerene’s thin cavity liner, which creates a closed system to prevent nitrous oxide leakage – eliminating the need for a cervical seal. 

• Thermally-insulating sheath. Cerene’s insulated probe sheath protects the cervical canal and adjacent tissues from cryoablative effects. The sheath is also radiopaque allowing for confirmation of the cryoprobe fundal placement under ultrasound visualization. 

• Controlled treatment parameters. Cerene not only adapts to the unique cavity length and structure of most patients, but also automatically monitors and controls certain variables (such as nitrous oxide flow and uterine cavity pressure) to ensure maximum patient safety. 

• Perforation prevention and detection. The Cerene Device has an atraumatic tip to limit the chances of perforation. Additionally, before treatment initiation, the Cerene device conducts safety tests to ensure the patient is kept safe from procedural burns. One of the safety tests is for detecting possible perforations of the uterine wall. If detected, the device will automatically shut down prior to administering the cryotherapy treatment. Cerene’s perforation detection technology is designed to prevent burning the deep myometrium, bowel, bladder, and other surrounding tissues.

• Cryotherapy using nitrous oxide. Cryoablation uses freezing technology to ablate the tissue without desiccation and collagen denaturation, which minimizes intracavitary scarring, adhesions, and contracture, and can help preserve future cavity access.⁵ Likewise, a 2021 clinical study evaluating Cerene reported no signs or symptoms of postablation tubal sterilization syndrome (PATSS).³  

See Cerene in Action

Cerene takes cryoablation one step further with next-generation safety features that help prevent burns and prioritize patient safety, with no device- or procedure-related serious adverse effects reported in the pivotal clinical study.³ Gynecologists who perform endometrial ablation with Cerene can help their patients realize long-term clinical benefits by delivering a safe, well-tolerated, and effective treatment for HMB.

Learn more about how Cerene maintains patient safety during endometrial ablation.

† Patient-reported data are 1 year after treatment with durable results at 3 years

Key Takeaways: 

• In addition to reducing blood loss and dysmenorrhea, one of the top priorities for gynecologists using endometrial ablation for HMB is patient safety.
• Both heat and cold based therapies promote different healing effects – with Cerene demonstrating minimized intrauterine adhesion formation post ablation.
• Cerene promotes safety during the ablation procedure with a cavity-conforming liner that prevents direct contact with nitrous oxide, perforation detection technology, a thermally-insulating sheath, and automatically-controlled treatment parameters.

Sources:

1. Endometrial Ablation for Heavy Menstrual Bleeding. (2021, October 25). U.S. Food & Drug Administration. https://www.fda.gov/medical-devices/surgery-devices/endometrial-ablation-heavy-menstrual-bleeding 
2. Carugno, J. & Fatehi, M. (2023, January 4). Abdominal Hysterectomy. In StatPearls. StatPearls Publishing. Retrieved July 25, 2023 from https://www.ncbi.nlm.nih.gov/books/NBK564366/ 
3. Curlin, H.L., Cintron, L.C., Anderson, T.L. (2021). A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding. Journal of Minimally Invasive Gynecology 28(4), 899-908.
4. Channel Medsystems, Inc. (2022). Cerene Device Instructions for Use (IFU-3243-Rev-G-Cerene-S1-IFU). Berkeley, CA: Author. Retrieved from https://cerene.com/wp-content/uploads/2022/11/IFU-3243-Rev-G-Cerene-S1-IFU.pdf. 
5. Curlin, H., Cholkeri-Singh, A., Leal, J.G.G., & Anderson, T. (2022). Hysteroscopic access and uterine cavity evaluation 12 months after endometrial ablation with the Cerene Cryotherapy Device. J Minim Invasive Gynecol, 29(3), 440-447. https://doi.org/10.1016/j.jmig.2021.11.016