NCT06406452 · University of Michigan
Bioresorbable Airway Splint Pivotal Clinical Trial
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject must have clinically significant tracheobronchomalacia and:
- be unable to wean off of mechanical ventilation, and/or
- be currently dependent on a tracheostomy tube, and/or
- 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
- Ann Arbor, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 21, 2026 · Source of record for eligibility and locations