RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-06-09
Study Completion:2025-12-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05922657

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.

Ages Eligible for Study:25 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Scheduled for a Cerene treatment
  2. * 25 years of age and older
  3. * Provided informed consent to participate in the registry
  4. * English speaking
  5. * Agrees to complete a survey at specified time points from baseline to 12 Months
  1. * Physician discretion
  2. * Vulnerable populations

Contacts and Locations

Study Contact

Gerard Reilly, MD
CONTACT
513-745-8881
Gerard.Reilly@axiawh.com
Brigette L. Tillman, RN
CONTACT
513-745-8881
Brigette.Tillman@axiawh.com

Principal Investigator

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

Study Locations (Sites)

Axia Women's Health / Rubino OB/GYN Group
West Orange, New Jersey, 07052
United States
Axia Women's Health / Seven Hills Women's Health Centers
Cincinnati, Ohio, 45255
United States

Collaborators and Investigators

Sponsor: Channel Medsystems

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-09
Study Completion Date2025-12-09

Study Record Updates

Study Start Date2023-06-09
Study Completion Date2025-12-09

Terms related to this study

Keywords Provided by Researchers

  • Cerene
  • Registry
  • Cryoablation

Additional Relevant MeSH Terms

  • Heavy Menstrual Bleeding
  • Abnormal Uterine Bleeding
  • Menorrhagia