Bioresorbable airway splint for treating airway collapse in children
A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable Tracheobronchial Splint in Pediatric Subjects With Clinically Significant Tracheobronchomalacia
NA · University of Michigan · NCT06406452
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 1 Week to 3 Years |
| Sex | All |
| Sponsor | University of Michigan (other) |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06406452 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: While this approach is innovative, similar studies using bioresorbable materials for airway support have shown promise, indicating potential for success.
Eligibility criteria
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 this trial is running
Ann Arbor, Michigan
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tracheobronchomalacia, Children, Airway splint, Three-dimensional printed, Multi-stie