Observational Study to Collect Real-World Data on the Cerene Cryotherapy Device for Heavy Menstrual Bleeding in Women 25 and Older

What this Trial Is About

Researchers are collecting real-world data on the Cerene Cryotherapy Device, which was approved by the FDA in 2019 for treating heavy menstrual bleeding in premenopausal women who have completed childbearing. This observational study aims to compare outcomes from routine clinical use of the Cerene device with results from previous pivotal studies, helping to understand its effectiveness and safety in everyday practice. Participants in this registry will have received treatment with the Cerene device as part of their standard medical care. The study does not involve any additional active interventions beyond this treatment. Data collection includes patient and physician surveys covering demographics, quality of life, procedural details, and clinical outcomes following the Cerene treatment. Women will participate for about 13 months, starting from enrollment and continuing through a 12-month follow-up after treatment. During this time, surveys will be completed at multiple points to assess re-intervention rates, quality of life, site of service, physician feedback, and cost analysis. The study concludes after the last participant completes her one-year follow-up visit.

A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device