RECRUITING

Bioresorbable Airway Splint Pivotal Clinical Trial

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Conditions

TracheobronchomalaciaChildrenAirway splintThree-dimensional printedMulti-stie

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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 purpose of this study is to learn if a three-dimensional (3D) printed airway splint device made to hold open a collapsing airway is a safe and effective treatment of Tracheobronchomalacia (TBM) in children. The airway splint is bioresorbable, meaning the child's body will absorb the splint over about five years.

Official Title

A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable Tracheobronchial Splint in Pediatric Subjects With Clinically Significant Tracheobronchomalacia

Quick Facts

Study Start:2025-01-07
Study Completion:2034-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06406452

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:1 Week to 3 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Subject must have clinically significant tracheobronchomalacia and:
  2. 1. be unable to wean off of mechanical ventilation, and/or
  3. 2. be currently dependent on a tracheostomy tube, and/or
  4. 3. meet current indications for a tracheostomy or another surgical intervention for TBM
  5. * Subjects must have a life expectancy of at least 2 years, exclusive of TBM
  6. * Subjects must have a parent or legal guardian capable of giving consent on behalf of the subject, and must be willing and able to complete the requirements of clinical trial follow-up
  7. * Subject must have a physician willing to provide follow-up clinical data, including a bronchoscopy at 2 years
  8. * Subjects must be greater than 1 week of age and less than 4 years of age. (Infant subjects born preterm, with low birth weight, or small for gestational age are eligible for trial enrollment if their comorbidities do not present a contraindication to surgical intervention for subjects TBM and airways are of a size that can appropriately be treated with the range of splint sizes offered in this clinical trial)
  1. * Subject has significant fixed anatomic tracheal stenosis
  2. * Subject has untreated complete tracheal rings
  3. * Subject has single-lung anatomy
  4. * Subject has single-ventricle cardiac anatomy
  5. * Subject has external compression due to active malignancy, active infection, or an undrained cyst
  6. * Subject has a non-bioresorbable airway stent. Recent removal of any stent will require verification of integrity of the airway wall
  7. * Subject has a contraindication to surgery other than airway compromise
  8. * Subject has a known hypersensitivity to polycaprolactone or hydroxyapatite, and/or a previous unusual reaction to bioresorbable sutures
  9. * Subject has a genetic defect of cartilage formation
  10. * Subject has significant bronchomalacia distal to the mainstem as the predominant source of subject's airway obstruction
  11. * Membranous posterior wall intrusion is the predominant form of collapse

Contacts and Locations

Study Contact

Andrea Les, PhD
CONTACT
734-998-5585
asles@umich.edu

Principal Investigator

Richard Ohye, MD
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

  • Richard Ohye, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

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 Date2025-01-07
Study Completion Date2034-03

Study Record Updates

Study Start Date2025-01-07
Study Completion Date2034-03

Terms related to this study

Keywords Provided by Researchers

  • Children
  • Airway splint
  • Three-dimensional printed
  • Multi-stie

Additional Relevant MeSH Terms

  • Tracheobronchomalacia