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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05922657
- Acronym / sponsor ID
- Progress / PTL-2023-N01
- Keywords
- Cerene, Registry, Cryoablation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Channel MedsystemsIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated patients | – | Device: CereneThis is a registry study with no active intervention outside standard of care. Women will be treated with Cerene per standard of care. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Physician discretion
- Vulnerable populations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CereneReal world use of Cerene. | Device | Treated patients |
Primary outcome
Re-intervention rate
Time frame: 12 Months
The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study.
Site of service rate
Time frame: 12 Months
The mix of Cerene treatments performed at different sites of service will be tabulated.
Patient quality of life
Time frame: 12 Months
The patient's quality of life at baseline and 12 Months will be compared.
2 secondary outcomes
Physician survey
Time frame: 12 Months
Cost analysis
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Results publication: PubMed 32835865Curlin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edward Yu, MBA study chair
EVP, Regulatory, Clinical & Medical Affairs and QA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heavy Menstrual Bleeding and Abnormal Uterine Bleeding, run by Channel Medsystems at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerard Reilly, MD (513-231-3447, gpreilly.shcrg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Re-intervention rate (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05922657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.