A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding.
Howard L Curlin, Laura Cédo Cintron, Ted L Anderson
https://pubmed.ncbi.nlm.nih.gov/32835865Actively Recruiting
Age: 25Years +
FEMALE
ID05922657
A Prospective, Observational, Multi-center Study to Gather Real World Use Data on the Effectiveness, Safety, and Site-of-service of the Cerene Device
Led by Channel Medsystems · Updated on 2025-12-16
300
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to collect real-world data on the Cerene Cryotherapy Device, which is used to treat heavy menstrual bleeding in premenopausal women who have completed childbearing. The goal is to compare outcomes from everyday use with those reported in earlier clinical studies, better understanding its effectiveness, safety, and usage in routine care. The study is observational and involves women receiving treatment as part of their usual care. Women enrolled in this registry will have undergone Cerene treatment according to standard care practices. The study will include up to 300 women, with no additional interventions beyond their normal medical treatment. Data will be gathered through patient and physician surveys covering demographics, quality of life, procedure details, and clinical outcomes from before treatment through 12 months after. Participants will be involved for about 13 months from enrollment to one year post-treatment. Surveys will be completed at baseline and at specified times during follow-up. Researchers will assess outcomes such as the need for further interventions, treatment location, and quality of life changes. Physician feedback and cost analysis will also be collected to provide a comprehensive understanding of the device's use in real-world settings.
CONDITIONS
Brief Title
A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
Who Can Participate
Age: 25Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Physician discretion
- Vulnerable populations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for informed consent and baseline survey
Implementation
Duration - Day of treatment
Participants undergo Cerene treatment as part of routine care with no additional intervention from the study.
1 visit for Cerene treatment
Long-term Monitoring
Duration - 12 months
Participants complete surveys to report clinical outcomes and quality of life for 12 months following treatment.
Multiple survey time points up to 12 months post treatment
Trial Site Locations
Total: 2 locations
1
Axia Women's Health / Rubino OB/GYN Group
West Orange, New Jersey, United States, 07052
Actively Recruiting
2
Seven Hills Women's Health Centers
Cincinnati, Ohio, United States, 45255
Actively Recruiting
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Research Team
G
Gerard Reilly, MD
B
Brigette L. Tillman, RN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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