A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device

Menorrhagia Clinical Trial

— Progress  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05922657
• Other study ID #: PTL-2023-N01
• Status: Recruiting
• Start date: June 9, 2023
• Est. completion date: July 9, 2025

Study information

• Verified date: July 2023
• Source: Channel Medsystems
• Contact: Gerard Reilly, MD
• Phone: 513-745-8881
• Email: Gerard.Reilly[@]axiawh.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Cerene was approved by the FDA in March 2019 for endometrial cryoablation in premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete. The primary objective of the Progress registry is to bridge the gap between clinical results and outcomes reported during the pivotal study of Cerene (the CLARITY Study) and those observed during its real-world use. The Progress registry will gather prospective, observational data on up to 300 women that underwent a Cerene treatment. Patients and physicians will complete surveys. Surveys will include patient demographic characteristics and quality of life measures at baseline, procedural details, and post-operative clinical outcomes and quality of life measures. Patient participation is expected to last approximately 13 months, from the time of patient enrollment to 12 months post treatment. The study will end after the last participating patient in completes her 12 month visit.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 9, 2025
• Est. primary completion date: June 9, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abnormal Uterine Bleeding
• Heavy Menstrual Bleeding
• Hemorrhage
• Menorrhagia
• Uterine Hemorrhage

Intervention

Device:
• Cerene
Real world use of Cerene.

Locations

Country	Name	City	State
United States	Axia Women's Health / Seven Hills Women's Health Centers	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Channel Medsystems

Country where clinical trial is conducted

United States, 

References & 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.2020.08.01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-intervention rate	The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study.	12 Months
Primary	Site of service rate	The mix of Cerene treatments performed at different sites of service will be tabulated.	12 Months
Primary	Patient quality of life	The patient's quality of life at baseline and 12 Months will be compared.	12 Months
Secondary	Physician survey	Each physician user will be surveyed on several topics related to the device.	12 Months
Secondary	Cost analysis	A cost analysis of Cerene treatments for different sites of service may be performed.	12 Months