A Prospective, Observational, Multi-center Study to Gather Real World Use Data on the Effectiveness, Safety, and Site-of-service of the Cerene Device
Channel Medsystems
Summary
Channel Medsystems, Inc., the manufacturer of the Cerene® Cryotherapy Device (Cerene), is initiating a prospective, observational registry, the Progress registry, to gather data during real world utilization of the Cerene® Cryotherapy Device (Cerene). The primary objective of this registry is to bridge the gap between clinical results and outcomes achieved and reported during the pivotal study of Cerene and those obtained during its real-world use.
Description
Cerene was approved by the FDA in March 2019 for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete. The primary objective of the Progress registry is to bridge the gap between clinical results and outcomes reported during the pivotal study of Cerene (the CLARITY Study) and those observed during its real-world use. The Progress registry will gather prospective, observational data on up to 300 women that underwent a Cerene treatment. Patients and physicians will complete surveys. Surveys will include patient demo…
Eligibility
- Age range
- 25+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Scheduled for a Cerene treatment * 25 years of age and older * Provided informed consent to participate in the registry * English speaking * Agrees to complete a survey at specified time points from baseline to 12 Months Exclusion Criteria: * Physician discretion * Vulnerable populations
Interventions
- DeviceCerene
Real world use of Cerene.
Locations (2)
- Axia Women's Health / Rubino OB/GYN GroupWest Orange, New Jersey
- Seven Hills Women's Health CentersCincinnati, Ohio