A Prospective, Observational, Multi-center Study to Gather Real World Use Data on the Effectiveness, Safety, and Site-of-service of the Cerene Device

What this Trial Is About

This research aims to collect real-world data on the Cerene Cryotherapy Device, which is used to treat heavy menstrual bleeding in premenopausal women who have completed childbearing. The goal is to compare outcomes from everyday use with those reported in earlier clinical studies, better understanding its effectiveness, safety, and usage in routine care. The study is observational and involves women receiving treatment as part of their usual care. Women enrolled in this registry will have undergone Cerene treatment according to standard care practices. The study will include up to 300 women, with no additional interventions beyond their normal medical treatment. Data will be gathered through patient and physician surveys covering demographics, quality of life, procedure details, and clinical outcomes from before treatment through 12 months after. Participants will be involved for about 13 months from enrollment to one year post-treatment. Surveys will be completed at baseline and at specified times during follow-up. Researchers will assess outcomes such as the need for further interventions, treatment location, and quality of life changes. Physician feedback and cost analysis will also be collected to provide a comprehensive understanding of the devices use in real-world settings.

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