A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
Progress
A Prospective, Observational, Multi-center Study to Gather Real World Use Data on the Effectiveness, Safety, and Site-of-service of the Cerene Device
1 other identifier
observational
300
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2023
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 9, 2023
CompletedFirst Submitted
Initial submission to the registry
June 12, 2023
CompletedFirst Posted
Study publicly available on registry
June 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
December 16, 2025
December 1, 2025
4.6 years
June 12, 2023
December 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Re-intervention rate
The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study.
12 Months
Site of service rate
The mix of Cerene treatments performed at different sites of service will be tabulated.
12 Months
Patient quality of life
The patient's quality of life at baseline and 12 Months will be compared.
12 Months
Secondary Outcomes (2)
Physician survey
12 Months
Cost analysis
12 Months
Study Arms (1)
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.
Interventions
Eligibility Criteria
Premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.
You may qualify if:
- Scheduled for a Cerene treatment
- 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 may not qualify if:
- Physician discretion
- Vulnerable populations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Axia Women's Health / Rubino OB/GYN Group
West Orange, New Jersey, 07052, United States
Seven Hills Women's Health Centers
Cincinnati, Ohio, 45255, United States
Related Publications (1)
Curlin HL, Cintron LC, Anderson TL. A Prospective, Multicenter, Clinical Trial Evaluating the Safety and Effectiveness of the Cerene Device to Treat Heavy Menstrual Bleeding. J Minim Invasive Gynecol. 2021 Apr;28(4):899-908. doi: 10.1016/j.jmig.2020.08.013. Epub 2020 Aug 22.
PMID: 32835865RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Edward Yu, MBA
Executive VP of Regulatory, Clinical, and Medical Affairs
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2023
First Posted
June 28, 2023
Study Start
June 9, 2023
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
December 16, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share