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New treatment option for Tracheobronchomalacia
Official title Bioresorbable Airway Splint Pivotal Clinical Trial
ClinicalTrials.gov ID: NCT06406452
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 3
You may be able to join if
- 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
- people must have a life expectancy of at least 2 years, exclusive of TBM
You likely can't join if
- 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
See the full eligibility 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
- people must have a life expectancy of at least 2 years, exclusive of TBM
- people 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
- people must be greater than 1 week of age and less than 4 years of age. (Infant people born preterm, with low birth weight, or small for gestational age are eligible for trial enrollment if their comorbidities do not...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 week to 3 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.