A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age25+
SponsorChannel Medsystems
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for a Cerene treatment
25 years of age and older
Provided informed consent to participate in the registry
English speaking
Disqualifiers
Physician discretion
Vulnerable populations
Trial population
Premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cerene
DeviceReal world use of Cerene.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Treated patients1 intervention
Trial outcomes
Primary outcomes
1
Re-intervention rate
The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study.
Time frame
12 Months2
Site of service rate
The mix of Cerene treatments performed at different sites of service will be tabulated.
Time frame
12 Months3
Patient quality of life
The patient's quality of life at baseline and 12 Months will be compared.
Time frame
12 MonthsSecondary outcomes
1
Physician survey
Each physician user will be surveyed on several topics related to the device.
Time frame
12 Months2
Cost analysis
A cost analysis of Cerene treatments for different sites of service may be performed.
Time frame
12 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov