Bioresorbable Airway Splint Pivotal Clinical Trial

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.

Conditions

Tracheobronchomalacia

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Study Overview

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Study Details

Study overview

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.

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

Bioresorbable Airway Splint Pivotal Clinical Trial

Condition
Tracheobronchomalacia
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

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

  • * Subject must have clinically significant tracheobronchomalacia and:
  • 1. be unable to wean off of mechanical ventilation, and/or
  • 2. be currently dependent on a tracheostomy tube, and/or
  • 3. meet current indications for a tracheostomy or another surgical intervention for TBM
  • * Subjects must have a life expectancy of at least 2 years, exclusive of TBM
  • * 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
  • * Subject must have a physician willing to provide follow-up clinical data, including a bronchoscopy at 2 years
  • * 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)
  • * Subject has significant fixed anatomic tracheal stenosis
  • * Subject has untreated complete tracheal rings
  • * Subject has single-lung anatomy
  • * Subject has single-ventricle cardiac anatomy
  • * Subject has external compression due to active malignancy, active infection, or an undrained cyst
  • * Subject has a non-bioresorbable airway stent. Recent removal of any stent will require verification of integrity of the airway wall
  • * Subject has a contraindication to surgery other than airway compromise
  • * Subject has a known hypersensitivity to polycaprolactone or hydroxyapatite, and/or a previous unusual reaction to bioresorbable sutures
  • * Subject has a genetic defect of cartilage formation
  • * Subject has significant bronchomalacia distal to the mainstem as the predominant source of subject's airway obstruction
  • * Membranous posterior wall intrusion is the predominant form of collapse

Ages Eligible for Study

1 Week to 3 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Michigan,

Richard Ohye, MD, PRINCIPAL_INVESTIGATOR, University of Michigan

Study Record Dates

2034-03