RECRUITING

CERAMENT G Device Registry

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

This is an Observational Device Registry Study of CERAMENT\|G in normal use in accordance with the IFU. It will run for a period of three years from enrolment of the first patient into the Study at each Site, before being subject to review. A Device Registry is a form of observational study that concerns the performance of a device in normal use. It is intended to collect data that is reflective of 'real world' device performance.

Official Title

CERAMENT G Device Registry

Quick Facts

Study Start:2023-08-17
Study Completion:2028-09-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06010433

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:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years and over (on the day of surgery)
  2. * receive CERAMENT\|G as a component of their treatment at a participating, contracted centre or healthcare provider, in accordance with the IFU for the implanted product
  3. * In receipt of patient information leaflet and have signed appropriately designed informed consent form.
  1. * Any exclusion criteria as per IFU for CERAMENT\|G
  2. * Any off-label use

Contacts and Locations

Study Contact

Brian M Bartholdi
CONTACT
16178923927
brian.bartholdi@bonesupport.com

Study Locations (Sites)

University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: BONESUPPORT AB

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 Date2023-08-17
Study Completion Date2028-09-22

Study Record Updates

Study Start Date2023-08-17
Study Completion Date2028-09-22

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Osteomyelitis
  • Fracture Related Infection
  • Diabetic Foot Osteomyelitis