A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
NCT05922657 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2025-12-16
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.
Conditions
- Heavy Menstrual Bleeding
- Abnormal Uterine Bleeding
- Menorrhagia
Interventions
- DEVICE
-
Cerene
Real world use of Cerene.
Sponsors & Collaborators
-
Channel Medsystems
lead INDUSTRY
Principal Investigators
-
Edward Yu, MBA · Executive VP of Regulatory, Clinical, and Medical Affairs
Eligibility
- Min Age
- 25 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-09
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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