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Recruiting
NCT05922657
A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
Conditions: Heavy Menstrual Bleeding, Abnormal Uterine Bleeding, Menorrhagia
Sex: Female
Ages: 25 Years – N/A
Healthy volunteers: No
Enrollment: 300
Sponsor: Channel Medsystems
Location: Axia Women's Health / Rubino OB/GYN Group West Orange New Jersey
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT05922657). StuddyBuddy aggregates publicly available trial information.
