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Registry for Cerene® Cryotherapy Device for Heavy Menstrual Bleeding

This study is a registry, called Progress, that collects information on how the Cerene® Cryotherapy Device is used in real-world settings. Cerene is a treatment for heavy menstrual bleeding (menorrhagia) in women who have completed childbearing. The goal is to see how well Cerene works and how it affects your quality of life outside of a controlled study. You can join if you are scheduled for a Cerene treatment, are 25 or older, speak English, and agree to complete surveys for about a year. The study aims to enroll up to 300 women. The study is currently unclear on its recruitment status.

Study design
This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include up to 300 women.
What's involved
You would complete surveys at the start of the study and at specific times up to 12 months after your Cerene treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after their Cerene treatment to assess re-intervention rates, site of service, and quality of life.

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NCT05922657

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

Recruiting
Not specifiedAges 25+Observational
Channel Medsystems
~300 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:Cerene

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Re-intervention rate
Measured over 12 Months
+2 more outcomes measured

Conditions

Heavy Menstrual Bleeding
Abnormal Uterine Bleeding
Menorrhagia

Explore related trials

Abnormal uterine bleedingMenorrhagia

Where it's being run

2 sites across 2 states
New Jersey1
Ohio1

Study leadership

  • Edward Yu, MBA · STUDY_CHAIR · EVP, Regulatory, Clinical & Medical Affairs and QA

Who to contact

Gerard Reilly, MD
[email protected]
513-231-3447
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Physician discretion
Vulnerable populations

What this trial measures

  • Re-intervention rate12 Months

    The cumulative re-intervention rate at 12 months will be compared to the pivotal clinical study.

  • Site of service rate12 Months

    The mix of Cerene treatments performed at different sites of service will be tabulated.

  • Patient quality of life12 Months

    The patient's quality of life at baseline and 12 Months will be compared.