An observational study in Heavy Menstrual Bleeding, Abnormal Uterine Bleeding and Menorrhagia, sponsored by Channel Medsystems. Recruiting at 2 sites in United States. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by Channel Medsystems · Observational
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.
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.
206 studies on the registry are indexed under Menorrhagia; 35 are open to participants now.
This study's planned enrollment of 300 is above the median of 210 across 47 observational studies indexed under Menorrhagia.
Browse Menorrhagia studies →Channel Medsystems is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This is a registry study with no active intervention outside standard of care. Women will be treated with Cerene per standard of care.
Device: Cerene
Real world use of Cerene.
Re-intervention rate
The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study.
Time frame: 12 Months
Site of service rate
The mix of Cerene treatments performed at different sites of service will be tabulated.
Time frame: 12 Months
Patient quality of life
The patient's quality of life at baseline and 12 Months will be compared.
Time frame: 12 Months
Physician survey
Each physician user will be surveyed on several topics related to the device.
Time frame: 12 Months
Cost analysis
A cost analysis of Cerene treatments for different sites of service may be performed.
Time frame: 12 Months
Not enrolling at this site.
Plan to share: No
Started Jun 2023 (actual). Primary completion is estimated for Dec 2027, 54 months after the start.
Of 21 observational studies under Menorrhagia, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 102. This study's planned 54 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Channel Medsystems