Bioresorbable Airway Splint Pivotal Clinical Trial

Official title

A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable Tracheobronchial Splint in Pediatric Subjects With Clinically Significant Tracheobronchomalacia

Overview

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.

Interventions

• Device 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 require

Primary outcome measures

• The proportion of subjects that survive to 6 months post-splinting [Time frame: 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 [Time frame: Approximately 4 weeks (±2 weeks) post splint implantation]

Secondary outcome measures (12)

• 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]

Eligibility criteria

Inclusion criteria

• 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)

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT06406452 · HUM00229974

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗