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

Channel Medsystems

Status: Enrolling

Conditions: Menorrhagia; Abnormal Uterine Bleeding; Heavy Menstrual Bleeding

Treatments: Device: Cerene

Study type: Observational

Funder types: Industry

Identifiers

NCT05922657

PTL-2023-N01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Treated patients

Description:

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

Treatment:

Device: Cerene