Heavy Menstrual BleedingAbnormal Uterine BleedingMenorrhagia
Investigational drug(s) / intervention(s)
Cerene
Cerene: Real world use of Cerene.
Study 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
Sex
FEMALE
Min age
25 Years
Max age
—
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
Primary outcome measure(s)
Re-intervention rate — 12 Months The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study.
Site of service rate — 12 Months The mix of Cerene treatments performed at different sites of service will be tabulated.
Patient quality of life — 12 Months The patient's quality of life at baseline and 12 Months will be compared.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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