Actively Recruiting
Bioresorbable Airway Splint Pivotal Clinical Trial
Led by University of Michigan · Updated on 2026-01-21
35
Participants Needed
1
Research Sites
477 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
M
Materialise
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Bioresorbable Airway Splint Pivotal Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child must have clinically significant tracheobronchomalacia and meet at least one: unable to wean off mechanical ventilation, dependent on a tracheostomy tube, or meet surgical indications for TBM
- Child must have life expectancy of at least 2 years excluding TBM
- Parent or legal guardian must be able to give consent and complete follow-up
- Child must have a physician willing to provide follow-up data including bronchoscopy at 2 years
- Child must be older than 1 week and younger than 4 years
- Child must have tracheobronchomalacia with less than 50% airway openness in trachea or mainstem bronchi based on CT, MRI, or bronchoscopy
- Surgeon must be able to safely access the affected airway area for splint placement
You will not qualify if you...
- Child has significant fixed tracheal narrowing
- Child has untreated complete tracheal rings
- Child has single-lung anatomy
- Child has single-ventricle heart anatomy
- Child has external airway compression from active cancer, infection, or undrained cyst
- Child has a non-bioresorbable airway stent or recent stent removal without airway integrity verification
- Child has surgical contraindications beyond airway issues
- Child has known allergy to polycaprolactone or hydroxyapatite or unusual reaction to bioresorbable sutures
- Child has genetic cartilage formation defects
- Child has predominant distal bronchomalacia as main airway obstruction
- Child has predominant collapse due to membranous posterior wall intrusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
A
Amy Hurst, BS
CONTACT
A
Andrea S Les, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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