A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable Tracheobronchial Splint in Pediatric Subjects With Clinically Significant Tracheobronchomalacia
University of Michigan
Summary
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.
Description
Other sites will be added to the registration as sites are on-boarded.
Eligibility
- Age range
- 0–3 years
- Sex
- All
- Healthy volunteers
- No
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 wil…
Interventions
- DeviceBioresorbable Tracheobronchial Splint
Subjects will have several imaging and bronchoscopic studies and the placement of the splint will require an open-chest surgery to implant the airway splint (s). The Materialise Bioresorbable Tracheobronchial Splint is designed for an individual subject based on Computed Tomography (CT) scans taken using a specific scan protocol. Based on these 3D models, a pre-operative plan is discussed between the Materialise engineering team and the treating surgeon(s) to determine the locations and required dimensions of the splint(s). Each subject may receive up to four splints positioned on subject's trachea or mainstem bronchi. Subjects will also have several follow-up visits, and parents will be expected to regularly fill out questionnaires.
Location
- University of MichiganAnn Arbor, Michigan