Bioresorbable Airway Splint Pivotal Clinical Trial

NCT ID: NCT06406452

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-07
• Study Completion Date: 2034-03-31

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.

Detailed Description

Other sites will be added to the registration as sites are on-boarded.

Conditions

Tracheobronchomalacia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bioresorbable Tracheobronchial Splint

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

Group Type: EXPERIMENTAL

Bioresorbable Tracheobronchial Splint

Intervention Type: 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.

Interventions

Bioresorbable Tracheobronchial Splint

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject must have clinically significant tracheobronchomalacia and:

1. be unable to wean off of mechanical ventilation, and/or

2. be currently dependent on a tracheostomy tube, and/or

3. 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

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

• Minimum Eligible Age: 1 Week
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Materialise

INDUSTRY

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Richard Ohye

Professor of Cardiac Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard G Ohye, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy Hurst, BS

Role: CONTACT

ahurst@umich.edu

734-232-0958

Andrea S Les, PhD

Role: CONTACT

asles@umich.edu

734-998-5585

Facility Contacts

Amy Hurst, BS

Role: primary

ahurst@umich.edu

734-232-0958

Andrea S Les, PhD

Role: backup

asles@umich.edu

734-998-5585

Other Identifiers

HUM00229974

Identifier Type: -

Identifier Source: org_study_id