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

Description

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.

Conditions

Heavy Menstrual Bleeding, Abnormal Uterine Bleeding, Menorrhagia

Study Overview

Study Details

Study overview

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.

A Prospective, Observational, Multi-center Study to Gather Real World Use Data on the Effectiveness, Safety, and Site-of-service of the Cerene Device

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

Condition
Heavy Menstrual Bleeding
Intervention / Treatment

-

Contacts and Locations

West Orange

Axia Women's Health / Rubino OB/GYN Group, West Orange, New Jersey, United States, 07052

Cincinnati

Axia Women's Health / Seven Hills Women's Health Centers, Cincinnati, Ohio, United States, 45255

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Physician discretion
  • * Vulnerable populations

Ages Eligible for Study

25 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Channel Medsystems,

Edward Yu, MBA, STUDY_CHAIR, Executive VP of Clinical, Medical, and Regulatory Affairs

Study Record Dates

2025-12-09