Registry to collect real-world data on the Cerene Cryotherapy Device
A Prospective, Observational, Multi-center Study to Gather Real World Use Data on the Effectiveness, Safety, and Site-of-service of the Cerene Device
This study is collecting information from women who are using the Cerene Cryotherapy Device to treat heavy menstrual bleeding to see how well it works in real life compared to clinical studies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 25 Years and up |
| Sex | Female |
| Sponsor | Channel Medsystems Industry-sponsored |
| Locations | 2 sites (West Orange, New Jersey and 1 other locations) |
| Trial ID | NCT05922657 on ClinicalTrials.gov |
What this trial studies
This registry aims to gather real-world utilization data on the Cerene® Cryotherapy Device, which is used for treating heavy menstrual bleeding in premenopausal women. The study will involve up to 300 women who are scheduled for Cerene treatment, collecting data through surveys that assess patient demographics, procedural details, and quality of life measures before and after treatment. The goal is to compare outcomes from real-world use with those reported in clinical studies, thereby enhancing understanding of the device's effectiveness in everyday settings.
Who should consider this trial
Good fit: Ideal candidates for this registry are women aged 25 and older who are scheduled for a Cerene treatment and can provide informed consent.
Not a fit: Patients who may not benefit from this registry include those who are not scheduled for Cerene treatment or belong to vulnerable populations as determined by physician discretion.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the real-world effectiveness and safety of the Cerene device, potentially improving treatment options for women with heavy menstrual bleeding.
How similar studies have performed: Other studies have successfully utilized observational registries to gather real-world data on medical devices, suggesting that this approach is both valid and valuable.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
West Orange, New Jersey and 1 other locations
- Axia Women's Health / Rubino OB/GYN Group — West Orange, New Jersey, United States (Recruiting)
- Seven Hills Women's Health Centers — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Gerard Reilly, MD
- Email: gpreilly.shcrg@gmail.com
- Phone: 513-231-3447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.