Bioresorbable Airway Splint Pivotal Clinical Trial

University of Michigan

Status

Enrolling

Conditions

Tracheobronchomalacia

Treatments

Device: Bioresorbable Tracheobronchial Splint

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06406452

HUM00229974

Details and patient eligibility

About

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.

Full description

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

Enrollment

35 estimated patients

Sex

All

Ages

1 week to 3 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

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