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

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ClinicalTrials.gov Identifier: NCT05922657
Recruitment Status : Recruiting
First Posted : June 28, 2023
Last Update Posted : July 11, 2023
Sponsor:
Information provided by (Responsible Party):
Channel Medsystems

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Heavy Menstrual Bleeding Abnormal Uterine Bleeding Menorrhagia Device: Cerene

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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
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
Actual Study Start Date : June 9, 2023
Estimated Primary Completion Date : June 9, 2025
Estimated Study Completion Date : July 9, 2025
Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Device: Cerene
Real world use of Cerene.


Outcome Measures
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Primary Outcome Measures :
  1. Re-intervention rate [ Time Frame: 12 Months ]
    The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study.

  2. Site of service rate [ Time Frame: 12 Months ]
    The mix of Cerene treatments performed at different sites of service will be tabulated.

  3. Patient quality of life [ Time Frame: 12 Months ]
    The patient's quality of life at baseline and 12 Months will be compared.


Secondary Outcome Measures :
  1. Physician survey [ Time Frame: 12 Months ]
    Each physician user will be surveyed on several topics related to the device.

  2. Cost analysis [ Time Frame: 12 Months ]
    A cost analysis of Cerene treatments for different sites of service may be performed.


Eligibility Criteria
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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05922657


Contacts
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Contact: Gerard Reilly, MD 513-745-8881 Gerard.Reilly@axiawh.com
Contact: Brigette L. Tillman, RN 513-745-8881 Brigette.Tillman@axiawh.com

Locations
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United States, Ohio
Axia Women's Health / Seven Hills Women's Health Centers Recruiting
Cincinnati, Ohio, United States, 45255
Contact: Gerard Reilly, MD    513-745-8881    Gerard.Reilly@axiawh.com   
Contact: Brigette L. Tillman, RN    513-745-8881    Brigette.Tillman@axiawh.com   
Sponsors and Collaborators
Channel Medsystems
Investigators
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Study Chair: Edward Yu, MBA Senior Executive VP of Clinical, Medical, and Regulatory Affairs
More Information
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Publications of Results:

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Responsible Party: Channel Medsystems
ClinicalTrials.gov Identifier: NCT05922657    
Other Study ID Numbers: PTL-2023-N01
First Posted: June 28, 2023    Key Record Dates
Last Update Posted: July 11, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Channel Medsystems:
Cerene
Registry
Cryoablation
Additional relevant MeSH terms:
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Uterine Hemorrhage
Menorrhagia
Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female
 Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Menstruation Disturbances