A Prospective, Observational, Multi-center Study to Gather Real World Use Data on the Effectiveness, Safety, and Site-of-service of the Cerene Device
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Healthy Volunteers: f
View:
• 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
Locations
United States
New Jersey
Axia Women's Health / Rubino OB/GYN Group
RECRUITING
West Orange
Ohio
Seven Hills Women's Health Centers
RECRUITING
Cincinnati
Contact Information
Primary
Gerard Reilly, MD
gpreilly.shcrg@gmail.com
513-231-3447
Backup
Brigette L. Tillman, RN
btillman.shcrg@gmail.com
513-231-3447
Time Frame
Start Date: 2023-06-09
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 300
Treatments
Treated patients
This is a registry study with no active intervention outside standard of care. Women will be treated with Cerene per standard of care.
Related Therapeutic Areas
Sponsors
Leads: Channel Medsystems