A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cerene.
- Who it may be relevant to
- Registry conditions: Heavy Menstrual Bleeding, Abnormal Uterine Bleeding, Menorrhagia. Basic parameters: from 25 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Device Cerene
Real world use of Cerene.
Primary outcome measures
- Re-intervention rate [Time frame: 12 Months]
- Site of service rate [Time frame: 12 Months]
- Patient quality of life [Time frame: 12 Months]
Secondary outcome measures (2)
- Physician survey [Time frame: 12 Months]
- Cost analysis [Time frame: 12 Months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Axia Women's Health / Rubino OB/GYN Group — West Orange
- Seven Hills Women's Health Centers — Cincinnati
Publications
- 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. PMID 32835865
Identifiers
NCT: NCT05922657 · PTL-2023-N01