Clinical trial NCT06406452: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tracheobronchomalacia
Keywords: Children
Airway splint
Three-dimensional printed
Multi-stie
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Materialise
First posted: 2024-05-09
Enrollment: 35
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

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

Primary outcomes:
measure: The proportion of subjects that survive to 6 months post-splinting
timeFrame: 6 months post splint implantation
measure: The Proportion of splinted regions with equal or greater than (≥) 50% average patency at approximately 4 weeks visit (window ±2 weeks) after splint implantation
timeFrame: Approximately 4 weeks (±2 weeks) post splint implantation
Secondary outcomes:
measure: 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
timeFrame: Approximately 4 weeks (±2 weeks) post splint implantation
measure: The proportion of splinted regions with ≥50% minimum patency approximately 4 weeks visit (window ±2 weeks) post splint implantation as measured by video bronchoscopy
timeFrame: Approximately 4 weeks (±2 weeks) post splint implantation
measure: The proportion of splinted regions with ≥50% minimum patency 2 years (window ± 4 months) post splint implantation
timeFrame: Approximately 2 years (window ± 4 months) post splint implantation
measure: Pediatric Quality of Life Inventory Infant Scales (PedsQL) Pre-operative (pre-op) - up to 1 year visit
timeFrame: Pre-op (prior to splint implementation), up to 1 year visit post splint implantation
measure: Pediatric Quality of Life Inventory Infant Scales (PedsQL) pre-op - up to 2 year visit
timeFrame: pre-op (prior to splint implementation), up to 2 year visit post splint implantation
measure: Pediatric Quality of Life Inventory Infant Scales (PedsQL) pre-op - up to 4 year visit
timeFrame: pre-op (prior to splint implementation), up to 4 year visit post splint implantation
measure: Pediatric Quality of Life Inventory Infant Scales (PedsQL) generic core scale post-op 2 year - up to 5 year visit
timeFrame: 2 year, up to 5 year visit post splint implantation
measure: Pediatric Quality of Life (PedsQL) Family Impact Module pre-op
timeFrame: Pre-op (prior to splint implementation)
measure: Pediatric Quality of Life (PedsQL) Family Impact Module 3 months post-op
timeFrame: 3 months post splint implantation
measure: Pediatric Quality of Life (PedsQL) Family Impact Module 6-months post-op
timeFrame: 6-months post splint implantation
measure: Pediatric Quality of Life (PedsQL) Family Impact Module 1 year post-op
timeFrame: 1 year post splint implantation
measure: Pediatric Quality of Life (PedsQL) Family Impact Module 2 years post-op
timeFrame: 2 years post splint implantation
measure: Pediatric Quality of Life (PedsQL) Family Impact Module 3 years post-op
timeFrame: 3 years post splint implantation
measure: Pediatric Quality of Life (PedsQL) Family Impact Module 4 years post-op
timeFrame: 4 years post splint implantation
measure: Pediatric Quality of Life (PedsQL) Family Impact Module 5 years post-op
timeFrame: 5 years post splint implantation
measure: The proportion of subjects with any device-related complication (DRC) at 6 months' post-implantation.
timeFrame: 6 months post splint implantation
measure: The proportion of subjects with any device-related complication (DRC) at 2 years post splint implantation
timeFrame: 2 years post splint implantation
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Richard G Ohye, MD
role: PRINCIPAL_INVESTIGATOR
References: