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New registry follows women using freezing device for heavy periods

NCT ID NCT05922657

Disease control Sponsor: Channel Medsystems Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is collecting information from 300 women who are scheduled to receive the Cerene cryotherapy device for heavy menstrual bleeding. The goal is to see how well the device works in everyday medical practice, how safe it is, and how it affects quality of life over 12 months. Participants will complete surveys and their re-treatment rates will be compared to earlier clinical trial results.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Premenopausal women with heavy menstrual bleeding due to benign causes for whom child bearing is complete.

Ages

25 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Menorrhagia Metrorrhagia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Abnormal uterine bleeding Heavy menstrual bleeding Menorrhagia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Axia Women's Health / Rubino OB/GYN Group

    COMPLETED

    West Orange, New Jersey, 07052, United States

  • Seven Hills Women's Health Centers

    RECRUITING

    Cincinnati, Ohio, 45255, United States

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