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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 demographic characteristics and quality of life measures at baseline, procedural details, and post-operative clinical outcomes and quality of life measures. Patient participation is expected to last approximately 13 months, from the time of patient enrollment to 12 months post treatment. The study will end after the last participating patient in completes her 12 month visit.

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

Conditions
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Heavy Menstrual Bleeding, Abnormal Uterine Bleeding, Menorrhagia

Intervention / Treatment
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* Device: Cerene


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated patients<br>This is a registry study with no active intervention outside standard of care. Women will be treated with Cerene per standard of care. | Device: Cerene<br>* Real world use of Cerene.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-intervention rate | The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study. | 12 Months | 
| Site of service rate | The mix of Cerene treatments performed at different sites of service will be tabulated. | 12 Months | 
| Patient quality of life | The patient's quality of life at baseline and 12 Months will be compared. | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician survey | Each physician user will be surveyed on several topics related to the device. | 12 Months | 
| Cost analysis | A cost analysis of Cerene treatments for different sites of service may be performed. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerene, Registry, Cryoablation