What this study is
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.
What's being tested
- Cerene
Intervention · DEVICE
Real world use of Cerene.
Study details
- 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
- Sponsor
- Channel Medsystems
- Conditions
- Heavy Menstrual Bleeding · Abnormal Uterine Bleeding · Menorrhagia
- Enrolling
- 300 people
- Starts
- 2023-06-09
- Est. completion
- 2027-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 25 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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 can't join if
- Physician discretion
- Vulnerable populations
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
1 openSeven Hills Women's Health Centers
Cincinnati, Ohio, United States
- Brigette L. Tillman, RN · Contact513-231-3447brigette_tillman@trihealth.com
- Gerard Reilly, MD · Principal investigator
RecruitingAxia Women's Health / Rubino OB/GYN Group
West Orange, New Jersey, United States
Completed
Study team
Sponsor
Channel Medsystems
Study ID PTL-2023-N01
Study chair
Edward Yu, MBA
EVP, Regulatory, Clinical & Medical Affairs and QA
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.