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

Recruiting

• Conditions: Abnormal Uterine Bleeding; Heavy Menstrual Bleeding; Menorrhagia
• Interventions: Device: Cerene

• Registration Number: NCT05922657
• Lead Sponsor: Channel Medsystems

Brief 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.

Study Timeline

• Study Start: 2023-06-09
• Study First Submitted: 2023-06-12
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-20
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-12-09
• Study Completion: 2025-12-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated patients	Cerene	This is a registry study with no active intervention outside standard of care. Women will be treated with Cerene per standard of care.

Primary Outcome Measures

Name	Time	Method
Patient quality of life	12 Months	The patient's quality of life at baseline and 12 Months will be compared.
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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Axia Women's Health / Rubino OB/GYN Group; 🇺🇸 West Orange, New Jersey, United States

Axia Women's Health / Seven Hills Women's Health Centers; 🇺🇸 Cincinnati, Ohio, United States