Bioresorbable airway splint for treating airway collapse in children
Official title: A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable Tracheobronchial Splint in Pediatric Subjects With Clinically Significant Tracheobronchomalacia
Run by University of Michigan · NCT06406452 · Data updated 2026-11-12
This study is testing a new 3D-printed airway splint to see if it can help children with airway collapse breathe better without needing a tracheostomy tube.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Week to 3 Years |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Status | Recruiting |
| Started | January 7, 2025 |
| Main results expected | September 2029 |
| Study ends | March 2034 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT06406452 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 1 week to 4 years with clinically significant tracheobronchomalacia who are unable to wean off mechanical ventilation or are dependent on a tracheostomy tube.
✕Probably not a fit
Patients who do not have clinically significant tracheobronchomalacia or those who are older than 4 years may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the safety and effectiveness of a three-dimensional printed bioresorbable airway splint designed to keep open the airway in children suffering from tracheobronchomalacia (TBM). The splint is intended for children who are unable to wean off mechanical ventilation or are dependent on a tracheostomy tube. The device is absorbed by the body over approximately five years, potentially providing a long-term solution for airway support. The study will involve multiple sites as they are onboarded to participate in the trial.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for children with severe airway collapse by reducing dependence on mechanical ventilation and tracheostomy tubes.
How similar studies have gone: While this approach is innovative, similar studies using bioresorbable materials for airway support have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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University of Michigan
Ann Arbor, Michigan, United States Recruiting
Study contacts
- Principal investigator: Richard G Ohye, MD — University of Michigan
- Study coordinator: Amy Hurst, BS
- Email: ahurst@umich.edu
- Phone: 734-232-0958
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using CPAP to improve walking distance in patients with airway collapse
This study is testing if using a CPAP machine can help people with airway collapse walk farther in six minutes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.