NCT05922657

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Channel Medsystems · Industry
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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.

Conditions

• Heavy Menstrual Bleeding
• Abnormal Uterine Bleeding
• Menorrhagia

Interventions

Type	Name	Description
DEVICE	Cerene	Real world use of Cerene.

Timeline

• Start date: 2023-06-09
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-06-28
• Last updated: 2025-12-16

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study