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

NCT ID: NCT05922657

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-09

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Heavy Menstrual Bleeding Abnormal Uterine Bleeding Menorrhagia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Cerene

Intervention Type DEVICE

Real world use of Cerene.

Interventions

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Cerene

Real world use of Cerene.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Channel Medsystems

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Yu, MBA

Role: STUDY_CHAIR

Executive VP of Regulatory, Clinical, and Medical Affairs

Locations

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Axia Women's Health / Rubino OB/GYN Group

West Orange, New Jersey, United States

Site Status RECRUITING

Seven Hills Women's Health Centers

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gerard Reilly, MD

Role: CONTACT

[email protected]
513-231-3447

Brigette L. Tillman, RN

Role: CONTACT

[email protected]
513-231-3447

Facility Contacts

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Joanne Serra, RN

Role: primary

[email protected]
862-444-2524

Brigette L. Tillman, RN

Role: primary

[email protected]
513-231-3447

References

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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.

Reference Type RESULT
PMID: 32835865 (View on PubMed)

Other Identifiers

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PTL-2023-N01

Identifier Type: -

Identifier Source: org_study_id