NCT05922657 A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
| NCT ID | NCT05922657 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Channel Medsystems |
| Condition | Heavy Menstrual Bleeding |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-06-09 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2023-06-09 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Edward Yu, MBA
STUDY CHAIR
EVP, Regulatory, Clinical & Medical Affairs and QA
Frequently Asked Questions
Who can join the NCT05922657 clinical trial?
This trial is open to female participants only, aged 25 Years or older, studying Heavy Menstrual Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05922657 currently recruiting?
Yes, NCT05922657 is actively recruiting participants. Contact the research team at gpreilly.shcrg@gmail.com for enrollment information.
Where is the NCT05922657 trial being conducted?
This trial is being conducted at West Orange, United States, Cincinnati, United States.
Who is sponsoring the NCT05922657 clinical trial?
NCT05922657 is sponsored by Channel Medsystems. The principal investigator is Edward Yu, MBA at EVP, Regulatory, Clinical & Medical Affairs and QA. The trial plans to enroll 300 participants.