Bioresorbable Airway Splint Pivotal Clinical Trial

NCT06406452 | Recruiting FDA Device

• 1 other identifier: HUM00229974
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tracheobronchomalacia

Keywords

Children; Airway splint; Three-dimensional printed; Multi-stie

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  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

  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

  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

  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

  pre-op (prior to splint implementation), up to 2 year visit post splint implantation

Study Arms (1)

Bioresorbable Tracheobronchial Splint

EXPERIMENTAL

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

Device: Bioresorbable Tracheobronchial Splint

Interventions

Bioresorbable Tracheobronchial Splint DEVICE

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.

Bioresorbable Tracheobronchial Splint

Eligibility Criteria

• Age: 1 Week - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify 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
• 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)
• \- 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
• \- The surgeon can safely dissect out the malacic trachea or bronchus/bronchi in order to place the splint

You may not qualify 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
• 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

Sponsors & Collaborators

• University of Michigan: lead
• Materialise: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Tracheobronchomalacia

Condition Hierarchy (Ancestors)

Cartilage Diseases; Musculoskeletal Diseases; Bronchial Diseases; Respiratory Tract Diseases; Tracheal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Officials

• Richard G Ohye, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Hurst, BS

CONTACT

734-232-0958; ahurst@umich.edu

Andrea S Les, PhD

CONTACT

734-998-5585; asles@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiac Surgery

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 9, 2024
• Study Start: January 7, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): March 1, 2034
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)