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.

Eligibility

Inclusion 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)

Patency-Based Pre-Operative Inclusion Criteria:

• Subjects must have tracheobronchomalacia in the trachea, left main bronchus, or right main bronchus a minimum patency of less than 50% in one of these regions
  • Screening: In order for a subject to be sent to a clinical trial site for evaluation for the clinical trial, a subject must have tracheobronchomalacia with evidence of less than 50% minimum patency based on a Computed Tomography Scan (CT), Magnetic resonance imaging (MRI), or bronchoscopic exam at referring institution confirmed by an imaging or operative note from the local physician.
  • At Enrollment: The subject must have tracheobronchomalacia with minimum patency of less than 50% in the trachea and/or left mainstem bronchus and/or right mainstem bronchus, based on expiration/inspiration CT performed at a clinical trial site performed during visit 1

Intra-Operative Inclusion Criteria:

• The surgeon can safely dissect out the malacic trachea or bronchus/bronchi in order to place the splint

Pre-Operative Exclusion Criteria:

• 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