Registry to collect real-world data on the Cerene Cryotherapy Device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This registry aims to gather real-world utilization data on the Cerene® Cryotherapy Device, which is used for treating heavy menstrual bleeding in premenopausal women. The study will involve up to 300 women who are scheduled for Cerene treatment, collecting data through surveys that assess patient demographics, procedural details, and quality of life measures before and after treatment. The goal is to compare outcomes from real-world use with those reported in clinical studies, thereby enhancing understanding of the device's effectiveness in everyday settings.

Why it matters

Who can join: the full rules

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

Where it's running

• Seven Hills Women's Health Centers
  Cincinnati, Ohio, United States Recruiting
• Axia Women's Health / Rubino OB/GYN Group
  West Orange, New Jersey, United States Completed

Study contacts

• Study coordinator: Gerard Reilly, MD
• Email: gpreilly.shcrg@gmail.com
• Phone: 513-231-3447

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• KLH-2109 for heavy menstrual bleeding from uterine fibroids

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• tAN to reduce heavy menstrual bleeding (LUNA)

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• Combined hysteroscopic and laparoscopic repair for cesarean scar niche

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.