COMPLETED

Biodesign® Otologic Repair Graft

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

The post-market follow-up clinical trial of the Cook® Biodesign® Otologic Repair Graft will follow patients up to 3 months post-implantation to determine the percent of patients with complete closure of the tympanic membrane.

Official Title

Post-market Real-world Collection Data for the Biodesign® Otologic Repair Graft

Quick Facts

Study Start:2021-09-29
Study Completion:2025-12-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04635228

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:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient requires tympanic membrane closure.
  1. * Life expectancy \< 12 months
  2. * Known sensitivity to porcine material

Contacts and Locations

Study Locations (Sites)

IU Health
Indianapolis, Indiana, 46202
United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
United States
University Hospitals-Cleveland
Cleveland, Ohio, 44106
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Cook Research Incorporated

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 Date2021-09-29
Study Completion Date2025-12-23

Study Record Updates

Study Start Date2021-09-29
Study Completion Date2025-12-23

Terms related to this study

Keywords Provided by Researchers

  • tympanoplasty
  • myringoplasty

Additional Relevant MeSH Terms

  • Tympanic Membrane Perforation
  • Eardrum Perforation