Clinical trial NCT05922657: A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
Official title: A Prospective, Observational, Multi-center Study to Gather Real World Use Data on the Effectiveness, Safety, and Site-of-service of the Cerene Device
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heavy Menstrual Bleeding
Abnormal Uterine Bleeding
Menorrhagia
Keywords: Cerene
Registry
Cryoablation
Lead sponsor: Channel Medsystems
Sponsor class: INDUSTRY
First posted: 2023-06-28
Enrollment: 300
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.

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.

Eligibility criteria: 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 outcomes:
measure: Re-intervention rate
timeFrame: 12 Months
measure: Site of service rate
timeFrame: 12 Months
measure: Patient quality of life
timeFrame: 12 Months
Secondary outcomes:
measure: Physician survey
timeFrame: 12 Months
measure: Cost analysis
timeFrame: 12 Months
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Axia Women's Health / Rubino OB/GYN Group
state: New Jersey
city: Cincinnati
country: United States
facility: Axia Women's Health / Seven Hills Women's Health Centers
state: Ohio
Study officials:
affiliation: Executive VP of Clinical, Medical, and Regulatory Affairs
name: Edward Yu, MBA
role: STUDY_CHAIR
References:
citation: Curlin HL, Cintron LC, Anderson TL. A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding. J Minim Invasive Gynecol. 2021 Apr;28(4):899-908. doi: 10.1016/j.jmig.2020.08.013. Epub 2020 Aug 22.