BERKELEY, Calif.–(BUSINESS WIRE)–Channel Medsystems, Inc., a medical device company whose mission is to empower every woman to take control of her health journey, today announced the release of long-term clinical results from the study. CLARITY clinic, evaluating the safety and efficacy of Cerene® Cryotherapy for the treatment of heavy menstrual bleeding (HMB) in the International Journal of Women’s Health.
The Cerene cryotherapy device is presented in this study as a well-tolerated endometrial ablation that can be performed consistently in the office, while providing a significant reduction in HMB symptoms and improved quality of life with great satisfaction for 3 years after treatment. The manuscript, titled “The Cerene® cryotherapy device for the treatment of heavy menstrual bleeding: 36-month results from the CLARITY study,” is available on the International Journal of Women’s Health website.
The CLARITY study was a prospective, multicenter, single-arm, open-label study that evaluated 242 premenopausal women who underwent cryoablation with Cerene. Follow-up assessments were performed at 12, 24 and 36 months. Two hundred and one patients completed a long-term follow-up visit at month 36 post-treatment.
Summary of main results:
Patient-reported reduced menstrual bleeding remained stable from months 12 to 36 – 90.9% of patients described their menstrual period as none, lighter than normal, or normal at 12 months, and 88.6% at 36 months .
High patient satisfaction and willingness to recommend Cerene to others remained consistent for 36 months. At 36 months, 85% of patients were ‘satisfied’ or ‘very satisfied’ and 91% would ‘definitely’ or ‘maybe’ recommend Cerene.
Improvements in patients’ quality of life were also maintained for 36 months after treatment. At 36 months, 91% of patients reported no or mild limitations in life activities. Eighty-five percent of patients reported being free of premenstrual symptoms “often”, “most often”, “very often” or “all the time” at month 36.
No serious device-related adverse events were reported in the study. After Cerene treatment, the cumulative incidence of medical and surgical interventions was low (8.7%).
“The results of the CLARITY study should give physicians confidence in the long-term benefits of Cerene endometrial cryoablation,” said lead author Howard L. Curlin, MD, Vanderbilt University Medical Center. “Heavy menstrual bleeding greatly diminishes a woman’s health. This study demonstrates that Cerene is a highly tolerable in-office treatment that relieves women of their heavy menstrual bleeding symptoms for three years, helping them regain their health.
“The 36-month results add to the growing body of evidence supporting the clinical utility, durability and safety profile of Cerene. The data confirms that this new treatment is a significant breakthrough for patients with HMB,” said Ric Cote, President and CEO of Channel Medsystems. “We look forward to continuing our commercialization efforts to bring Cerene to more physicians and their patients across the country. »
About Cerene Cryotherapy
Cerene is an in-office endometrial cryoablation treatment that safely and effectively reduces heavy menstrual bleeding while naturally minimizing pain without the need for general anesthesia. Cerene FDA’s pivotal clinical study (“CLARITY”), published in The Journal of Minimally Invasive Gynecology, concluded that 90% of all patients had improvement in bleeding symptoms and were satisfied with the procedure 12 months after treatment. Moreover, the results published in The Journal of Minimally Invasive Gynecology in November 2021 demonstrated that the use of cryoablation to treat the endometrium preserved access to the uterine cavity, with visualization in 91% of patients assessed, and the ability to assess pathological changes in 96% of patients whose uterine cavities could be fully visualized.
About Channel Medsystems
Channel Medsystems® is a private company dedicated to empowering every woman to take control of her health journey and live her best life. Committed to providing innovative technologies that exceed the expectations of women and their gynecologists, Channel strives to develop easy-to-use, safe and cost-effective medical devices that deliver exceptional outcomes and superior patient comfort, accessible to all the women. . Channel Medsystems, Inc. is headquartered in Berkeley, California.
For more information, visit www.cerene.com and follow us on LinkedIn.