Airway Splint for Bronchomalacia

Overseen By Andrea S Les, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Tracheal stenosis, Single-lung anatomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Hospital stay

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for children with tracheobronchomalacia (TBM), a condition where weak airway walls collapse, making breathing difficult. The treatment uses a 3D-printed splint (bioresorbable tracheobronchial splint) to support the airways, gradually absorbing into the body over five years. It targets children who rely on machines to breathe or have a tracheostomy tube. This trial may suit children who cannot breathe independently due to TBM and have no other major health issues that would make surgery risky. As an unphased trial, it offers a unique opportunity for children to access innovative treatment options not yet widely available.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What prior data suggests that this airway splint is safe for children with Tracheobronchomalacia?

Research has shown that the bioresorbable tracheobronchial splint, a 3D-printed device, is generally well-tolerated in children with breathing problems. In case studies, children with serious airway issues used this splint and did not experience airway narrowing or collapse after the procedure.

The splint is designed to be absorbed by the body over five years and has shown early success in helping children breathe more easily. No major reports of negative effects have been linked to the splint.

These findings suggest that the splint could be a safe option for children with airway issues. However, more research is needed to understand its long-term safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for bronchomalacia involve supportive care like positive airway pressure or surgical options like tracheostomy to keep the airways open. However, the bioresorbable tracheobronchial splint is unique because it provides structural support to the weakened airways directly, allowing them to stay open. This splint is made from a material that gradually dissolves in the body, eliminating the need for additional surgeries to remove it. Researchers are excited about this treatment because it offers a less invasive and potentially more effective solution for maintaining open airways compared to current options.

What evidence suggests that this airway splint is effective for Tracheobronchomalacia?

Research has shown that 3D-printed, bioresorbable airway splints effectively treat severe airway collapse in children. In one study, children with this condition improved their breathing after receiving the splint. Another study followed patients for about 20 months and found that some experienced a resolution of their breathing problems. Participants in this trial will receive the Bioresorbable Tracheobronchial Splint, designed to keep the airway open and gradually absorbed by the child's body over five years. This innovative approach offers a promising solution for children with Tracheobronchomalacia (TBM), a condition where the airways collapse and cause breathing difficulties. ^{1 2 3 6 7}

Who Is on the Research Team?

Richard G Ohye, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for children with Tracheobronchomalacia (TBM), a condition where the airway collapses and makes breathing difficult. The child's body should be able to absorb bioresorbable materials over time.

Inclusion Criteria

My airways are at least 50% blocked, confirmed by a CT scan.

I have a condition where my airways collapse by more than half.

Subjects must have a life expectancy of at least 2 years, exclusive of TBM

Exclusion Criteria

Subject has single-ventricle cardiac anatomy

I have a severe narrowing in my windpipe.

I have a permanent airway stent or recently had one removed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative Assessment

Participants undergo pre-operative assessments including Pediatric Quality of Life Inventory Infant Scales (PedsQL)

Up to 4 weeks

Treatment

Participants are admitted to the hospital for the assessment and placement of the bioresorbable tracheobronchial splint

Hospital stay

Initial Follow-up

Participants are monitored for splint patency and device-related complications

6 months

Regular visits for monitoring

Extended Follow-up

Long-term follow-up to assess Pediatric Quality of Life and device-related complications

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Bioresorbable Tracheobronchial Splint

Trial Overview The study is testing a 3D printed, bioresorbable airway splint designed to support a collapsing airway in children with TBM. It aims to determine if this treatment is safe and effective.

How Is the Trial Designed?

Group I: Bioresorbable Tracheobronchial Splint Experimental Treatment 1 Intervention

Participants are admitted to the hospital for this assessment and placement of the splint.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Materialise

Industry Sponsor

Trials

4

Recruited

70+

Published Research Related to This Trial

A study involving nine infants with severe tracheomalacia showed that personalized 3D-printed bioresorbable airway external splints effectively relieved respiratory symptoms without complications, supporting their safety and efficacy as a treatment option.

The splints provided support for at least 6 months and were designed to degrade safely over 2-3 years, allowing for airway growth while preventing collapse, making them a promising alternative to traditional surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized 3D-Printed Bioresorbable Airway External Splint for Tracheomalacia Combined With Congenital Heart Disease. Yu, D., Peng, W., Mo, X., et al.[2022]

In a case series of 15 critically ill children with severe tracheobronchomalacia, the use of 3D-printed bioresorbable airway splints led to significant improvements in respiratory support, with a median reduction in positive end-expiratory pressure (PEEP) of -2.5 cm H2O after implantation.

At a median follow-up of 8.5 months, most surviving subjects were able to live at home, with notable advancements in their respiratory independence, including one child being decannulated and others reducing their reliance on ventilators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D-printed, externally-implanted, bioresorbable airway splints for severe tracheobronchomalacia. Les, AS., Ohye, RG., Filbrun, AG., et al.[2020]

A novel treatment using 3D-printed, patient-specific, bioresorbable airway splints has been investigated in 15 critically ill children with severe tracheobronchomalacia, showing promising results with 12 long-term survivors after a median follow-up of 8.5 months.

This innovative approach offers a potential alternative to more invasive therapies like tracheostomy and mechanical ventilation, highlighting its efficacy in managing severe cases of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced Therapies for Severe Tracheobronchomalacia: A Review of the Use of 3D-Printed, Patient-Specific, Externally Implanted, Bioresorbable Airway Splints. Sood, V., Green, GE., Les, A., et al.[2021]

A surgical procedure using a silastic reinforced marlex mesh splint was successfully performed on 4 children (3 with tracheomalacia and 1 with bronchomalacia) to support their collapsing airways, with no complications reported.

The splint effectively eliminated symptoms of airway collapse in all patients, suggesting it is a viable treatment option for cases where other methods have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of segmental tracheomalacia and bronchomalacia by implantation of an airway splint. Filler, RM., Buck, JR., Bahoric, A., et al.[2019]

In a study of 5 pediatric patients with severe tracheomalacia or tracheobronchomalacia, the use of bioabsorbable airway supportive devices (ASD) led to successful weaning from respiratory support in 4 out of 5 cases, demonstrating their potential efficacy in critical airway management.

Pre-operative 3D airway modeling was crucial for optimizing the placement of sutures on the ASDs, which helped improve airway patency and overall treatment outcomes, highlighting the importance of careful planning in complex cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External airway splint placement for severe pediatric tracheobronchomalacia. Brooks, KA., Lai, AY., Tucker, SJ., et al.[2023]

In a study involving 14 children with severe airway collapse, the use of novel external bioresorbable splints provided effective temporary support, allowing for airway growth while addressing structural issues.

Most patients showed improvement, with 4 requiring no further interventions and several others needing less intensive mechanical ventilation, indicating the splints' potential in managing severe tracheobronchomalacia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with bioresorbable splints for treatment of airway collapse in a pediatric population. Kamran, A., Smithers, CJ., Baird, CW., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8350796/

Experience with bioresorbable splints for treatment of airway ... With a median follow-up of 20 months (interquartile range, 12-21 months), 4 patients demonstrated resolution of respiratory signs and symptoms without any ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06406452

NCT06406452 | Bioresorbable Airway Splint Pivotal ... A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable Tracheobronchial Splint in Pediatric Subjects With Clinically Significant ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06406452?cond=Bronchomalacia&viewType=Table&rank=3

Study Details | Bioresorbable Airway Splint Pivotal ... A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable Tracheobronchial Splint in Pediatric Subjects With Clinically Significant ...

4. withpower.com withpower.com/trial/phase-tracheobronchomalacia-4-2024-01ca2

Airway Splint for Bronchomalacia Research shows that 3D-printed, bioresorbable airway splints have been effective in treating severe airway collapse in children, with improvements in breathing ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6662576/

3D-printed, externally-implanted, bioresorbable airway ... This case series demonstrates the initial clinical efficacy of the 3D-printed bioresorbable airway splint device in a cohort of critically ill children with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9127074/

Personalized 3D-Printed Bioresorbable Airway External ... Postoperative flexible bronchoscopy showed no tracheal and/or bronchial stenosis or malacia (Figure 1), and the respiratory symptoms were relieved in all ...

7. ctv.veeva.com ctv.veeva.com/study/bioresorbable-airway-splint-pivotal-clinical-trial

Bioresorbable Airway Splint Pivotal Clinical Trial 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 ...