TracheobronchomalaciaNCT06406452
Bioresorbable Airway Splint Pivotal Clinical Trial
A study testing Bioresorbable Tracheobronchial Splint in people with Tracheobronchomalacia, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 week to 3 years
- Conditions the study is for
- Tracheobronchomalacia
- What is being tested?
- Bioresorbable Tracheobronchial Splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2025to Mar 2034
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 26Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Amy Hurst, BS, 734-232-0958, ahurst@umich.edu
Andrea S Les, PhD, 734-998-5585, asles@umich.edu
About this study
Official title: A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable Tracheobronchial Splint in Pediatric Subjects With Clinically Significant Tracheobronchomalacia
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.
Read the detailed description
Other sites will be added to the registration as sites are on-boarded.
- Conditions
- Tracheobronchomalacia
- Being tested
- Bioresorbable Tracheobronchial Splint
- Keywords
- Children, Airway splint, Three-dimensional printed, Multi-stie
- Medical subject headings
- Tracheobronchomalacia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioresorbable Tracheobronchial SplintDevice
Subjects will have several imaging and bronchoscopic studies and the placement of the splint will require an open-chest surgery to implant the airway splint (s).
The Materialise Bioresorbable Tracheobronchial Splint is designed for an individual subject based on Computed Tomography (CT) scans taken using a specific scan protocol. Based on these 3D models, a pre-operative plan is discussed between the Materialise engineering team and the treating surgeon(s) to determine the locations and required dimensions of the splint(s). Each subject may receive up to four splints positioned on subject's trachea or mainstem bronchi.
Subjects will also have several follow-up visits, and parents will be expected to regularly fill out questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Bioresorbable Tracheobronchial Splint | Experimental | Participants are admitted to the hospital for this assessment and placement of the splint. Receives: Device: Bioresorbable Tracheobronchial Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects that survive to 6 months post-splinting
All-cause mortality within 6 months (180 days) of splint implantation will count against this endpoint.
Measured: 6 months post splint implantation
The Proportion of splinted regions with equal or greater than (≥) 50% average patency at approximately 4 weeks visit (window ±2 weeks) after splint implantation
This will be measured by inspiratory/expiratory cat scan (CT), where average patency is defined as: average cross-sectional area in splinted region on expiration divided by average cross-sectional area in splinted region on inspiration.
Measured: Approximately 4 weeks (±2 weeks) post splint implantation
Secondary outcomes (17)
The proportion of splinted regions with an absolute increase in average patency of ≥20% from pre-op to approximately 4 weeks visit (window ±2 weeks) post splint implantation
This will be measured by inspiratory/expiratory CT, where average patency is defined as: average cross-sectional area in splinted region on expiration divided by average cross-sectional area in splinted region on inspiration.
Measured: Approximately 4 weeks (±2 weeks) post splint implantation
The proportion of splinted regions with ≥50% minimum patency approximately 4 weeks visit (window ±2 weeks) post splint implantation as measured by video bronchoscopy
The percent patency is defined as: observed diameter/expected diameter based upon adjacent non-affected areas x 100, as assessed by the Imaging Core Lab.
Measured: Approximately 4 weeks (±2 weeks) post splint implantation
The proportion of splinted regions with ≥50% minimum patency 2 years (window ± 4 months) post splint implantation
The percent patency is defined as: observed diameter/expected diameter based upon adjacent non-affected areas x 100, as assessed by the Imaging Core Lab.
Measured: Approximately 2 years (window ± 4 months) post splint implantation
Pediatric Quality of Life Inventory Infant Scales (PedsQL) Pre-operative (pre-op) - up to 1 year visit
This will be collected for participants (age 0-12 months) This 36-item module measures parent self-reported functioning in physical (6 items), emotional (5 items), social (4 items), and cognitive (5 items) domains, communication (3 items), and worry (5 items), as well as two scales measuring parent-reported family functioning: daily activities (3 items) and family relationships (5 items). Items are reverse-scored and linearly transformed to a 0-100 scale, such that the minimum score is 0 and the maximum score is 100. A higher score indicates better quality of life.
Measured: Pre-op (prior to splint implementation), up to 1 year visit post splint implantation
Pediatric Quality of Life Inventory Infant Scales (PedsQL) pre-op - up to 2 year visit
This will be collected for participants (ages 13-24 months). This 45-item module measures parent self-reported physical functioning (9 items), physical symptoms (10 items), emotional functioning (12 items), and social functioning (5 items) domains, cognitive functioning (9 items). Items are reverse-scored and linearly transformed to a 0-100 scale, such that the minimum score is 0 and the maximum score is 100. A higher score indicates better quality of life.
Measured: pre-op (prior to splint implementation), up to 2 year visit post splint implantation
Pediatric Quality of Life Inventory Infant Scales (PedsQL) pre-op - up to 4 year visit
This will be collected for participants (ages 2-4 years). This 21-item module measures parent self-reported physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Items are reverse-scored and linearly transformed to a 0-100 scale, such that the minimum score is 0 and the maximum score is 100. A higher score indicates better quality of life.
Measured: pre-op (prior to splint implementation), up to 4 year visit post splint implantation
Pediatric Quality of Life Inventory Infant Scales (PedsQL) generic core scale post-op 2 year - up to 5 year visit
This will be collected for participants (ages 5-7 years old, 8-12 years) This 23-item module measures parent self-reported physical functioning (8 items), emotional (5 items), social functioning (5 items) and school functioning (5 items). Items are reverse-scored and linearly transformed to a 0-100 scale, such that the minimum score is 0 and the maximum score is 100. A higher score indicates better quality of life.
Measured: 2 year, up to 5 year visit post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module pre-op
There are 36 questions that will be completed from a likert scale of never 0-almost always 4. The Pediatric Quality of Life Family Impact Module (PEDSQL) Score range 0-100. Higher score better quality of life.
Measured: Pre-op (prior to splint implementation)
Pediatric Quality of Life (PedsQL) Family Impact Module 3 months post-op
There are 36 questions that will be completed from a likert scale of never 0-almost always 4. The Pediatric Quality of Life Family Impact Module (PEDSQL) Score range 0-100. Higher score better quality of life.
Measured: 3 months post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 6-months post-op
There are 36 questions that will be completed from a likert scale of never 0-almost always 4. The Pediatric Quality of Life Family Impact Module (PEDSQL) Score range 0-100. Higher score better quality of life.
Measured: 6-months post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 1 year post-op
There are 36 questions that will be completed from a likert scale of never 0-almost always 4. The Pediatric Quality of Life Family Impact Module (PEDSQL) Score range 0-100. Higher score better quality of life.
Measured: 1 year post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 2 years post-op
The PedsQL consists of 36 items in eight dimensions: physical functioning, emotional functioning, social functioning, cognitive functioning, communication, worry, daily activities and family relationships that measures health related quality of life. The questionnaire asks how much of a problem each item has been during the past month. Each item is answered on a scale of 0 (never) to 4 (almost always) then the scores are transformed to a 0 to 100 scale, so that higher scores indicate better heath related quality of life.
Measured: 2 years post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 3 years post-op
The PedsQL consists of 36 items in eight dimensions: physical functioning, emotional functioning, social functioning, cognitive functioning, communication, worry, daily activities and family relationships that measures health related quality of life. The questionnaire asks how much of a problem each item has been during the past month. Each item is answered on a scale of 0 (never) to 4 (almost always) then the scores are transformed to a 0 to 100 scale, so that higher scores indicate better heath related quality of life.
Measured: 3 years post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 4 years post-op
The PedsQL consists of 36 items in eight dimensions: physical functioning, emotional functioning, social functioning, cognitive functioning, communication, worry, daily activities and family relationships that measures health related quality of life. The questionnaire asks how much of a problem each item has been during the past month. Each item is answered on a scale of 0 (never) to 4 (almost always) then the scores are transformed to a 0 to 100 scale, so that higher scores indicate better heath related quality of life.
Measured: 4 years post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 5 years post-op
The PedsQL consists of 36 items in eight dimensions: physical functioning, emotional functioning, social functioning, cognitive functioning, communication, worry, daily activities and family relationships that measures health related quality of life. The questionnaire asks how much of a problem each item has been during the past month. Each item is answered on a scale of 0 (never) to 4 (almost always) then the scores are transformed to a 0 to 100 scale, so that higher scores indicate better heath related quality of life.
Measured: 5 years post splint implantation
The proportion of subjects with any device-related complication (DRC) at 6 months' post-implantation.
A DRC will be defined as a subset of Serious Adverse Events (SAE) that are determined to be definitely, probably, or possibly related to the device.
Measured: 6 months post splint implantation
The proportion of subjects with any device-related complication (DRC) at 2 years post splint implantation
A DRC will be defined as a subset of Serious Adverse Events (SAE) that are determined to be definitely, probably, or possibly related to the device
Measured: 2 years post splint implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start7 Jan 2025
- Primary completionSep 2029 (estimated)
- Study completionMar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TracheobronchomalaciaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Materialise
- Responsible party
- Principal investigator, Richard Ohye, University of Michigan
- Investigators
- Richard G Ohye, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406452
- Sponsor's protocol ID
- HUM00229974
- Status last verified
- Jan 2026
- First submitted
- 2 May 2024
- Last updated
- 21 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable Tracheobronchial Splint in Pediatric Subjects With Clinically Significant Tracheobronchomalacia
- ClinicalTrials.gov ID
- NCT06406452
- Acronym / sponsor ID
- HUM00229974
- Conditions
- Tracheobronchomalacia
- Keywords
- Children, Airway splint, Three-dimensional printed, Multi-stie
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Materialise
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Mar 2034 (estimated)
- First posted
- 9 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Other sites will be added to the registration as sites are on-boarded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bioresorbable Tracheobronchial Splint | Experimental | Device: Bioresorbable Tracheobronchial SplintParticipants are admitted to the hospital for this assessment and placement of the splint. |
Who may qualify
- Ages
- 1 week to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (26 listed)
- Subject must have clinically significant tracheobronchomalacia and:
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioresorbable Tracheobronchial SplintSubjects will have several imaging and bronchoscopic studies and the placement of the splint will require an open-chest surgery to implant the airway splint (s). The Materialise Bioresorbable Tracheobronchial Splint is designed for an individual subject based on Computed Tomography (CT) scans taken using a specific scan protocol. Based on these 3D models, a pre-operative plan is discussed between the Materialise engineering team and the treating surgeon(s) to determine the locations and required dimensions of the splint(s). Each subject may receive up to four splints positioned on subject's trachea or mainstem bronchi. Subjects will also have several follow-up visits, and parents will be expected to regularly fill out questionnaires. | Device | Bioresorbable Tracheobronchial Splint |
Primary outcome
The proportion of subjects that survive to 6 months post-splinting
Time frame: 6 months post splint implantation
All-cause mortality within 6 months (180 days) of splint implantation will count against this endpoint.
The Proportion of splinted regions with equal or greater than (≥) 50% average patency at approximately 4 weeks visit (window ±2 weeks) after splint implantation
Time frame: Approximately 4 weeks (±2 weeks) post splint implantation
This will be measured by inspiratory/expiratory cat scan (CT), where average patency is defined as: average cross-sectional area in splinted region on expiration divided by average cross-sectional area in splinted region on inspiration.
17 secondary outcomes
The proportion of splinted regions with an absolute increase in average patency of ≥20% from pre-op to approximately 4 weeks visit (window ±2 weeks) post splint implantation
Time frame: Approximately 4 weeks (±2 weeks) post splint implantation
The proportion of splinted regions with ≥50% minimum patency approximately 4 weeks visit (window ±2 weeks) post splint implantation as measured by video bronchoscopy
Time frame: Approximately 4 weeks (±2 weeks) post splint implantation
The proportion of splinted regions with ≥50% minimum patency 2 years (window ± 4 months) post splint implantation
Time frame: Approximately 2 years (window ± 4 months) post splint implantation
Pediatric Quality of Life Inventory Infant Scales (PedsQL) Pre-operative (pre-op) - up to 1 year visit
Time frame: Pre-op (prior to splint implementation), up to 1 year visit post splint implantation
Pediatric Quality of Life Inventory Infant Scales (PedsQL) pre-op - up to 2 year visit
Time frame: pre-op (prior to splint implementation), up to 2 year visit post splint implantation
Pediatric Quality of Life Inventory Infant Scales (PedsQL) pre-op - up to 4 year visit
Time frame: pre-op (prior to splint implementation), up to 4 year visit post splint implantation
Pediatric Quality of Life Inventory Infant Scales (PedsQL) generic core scale post-op 2 year - up to 5 year visit
Time frame: 2 year, up to 5 year visit post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module pre-op
Time frame: Pre-op (prior to splint implementation)
Pediatric Quality of Life (PedsQL) Family Impact Module 3 months post-op
Time frame: 3 months post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 6-months post-op
Time frame: 6-months post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 1 year post-op
Time frame: 1 year post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 2 years post-op
Time frame: 2 years post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 3 years post-op
Time frame: 3 years post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 4 years post-op
Time frame: 4 years post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 5 years post-op
Time frame: 5 years post splint implantation
The proportion of subjects with any device-related complication (DRC) at 6 months' post-implantation.
Time frame: 6 months post splint implantation
The proportion of subjects with any device-related complication (DRC) at 2 years post splint implantation
Time frame: 2 years post splint implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard G Ohye, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bioresorbable Tracheobronchial Splint in people with Tracheobronchomalacia, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy Hurst, BS (734-232-0958, ahurst@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects that survive to 6 months post-splinting (time frame: 6 months post splint implantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.