Heavy Menstrual BleedingProgressNCT05922657
A Registry to Gather Real World Use Data on the Cerene® Cryotherapy Device
An observational study of Heavy Menstrual Bleeding and Abnormal Uterine Bleeding, run by Channel Medsystems at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 25 years and older, women only
- Conditions the study is for
- Heavy Menstrual Bleeding, Abnormal Uterine Bleeding, Menorrhagia
- What is being tested?
- Cerene
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Jun 2023to 31 Dec 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.
Who may be able to join
- 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
Who cannot join
- Physician discretion
- Vulnerable populations
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 1 recruiting
- Recruiting
Seven Hills Women's Health Centers
Cincinnati, Ohio, 45255
Brigette L. Tillman, RN, 513-231-3447, brigette_tillman@trihealth.com
Gerard Reilly, MD
- Completed
Axia Women's Health / Rubino OB/GYN Group
West Orange, New Jersey, 07052
About this study
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
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.
Read the detailed 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.
- Being tested
- Cerene
- Keywords
- Cerene, Registry, Cryoablation
- Medical subject headings
- Menorrhagia, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CereneDevice
Real world use of Cerene.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cerene |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-intervention rate
The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study.
Measured: 12 Months
Site of service rate
The mix of Cerene treatments performed at different sites of service will be tabulated.
Measured: 12 Months
Patient quality of life
The patient's quality of life at baseline and 12 Months will be compared.
Measured: 12 Months
Secondary outcomes (2)
Physician survey
Each physician user will be surveyed on several topics related to the device.
Measured: 12 Months
Cost analysis
A cost analysis of Cerene treatments for different sites of service may be performed.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start9 Jun 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heavy Menstrual BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Channel Medsystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Yu, MBA, Study chair, EVP, Regulatory, Clinical & Medical Affairs and QA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922657
- Sponsor's protocol ID
- PTL-2023-N01
- Acronym
- Progress
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2023
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32835865