NCT06406452

Bioresorbable Airway Splint Pivotal Clinical Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 1 Week – 3 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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 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.

Timeline

• Start date: 2025-01-07
• Primary completion: 2029-09-01
• Completion: 2034-03-01
• First posted: 2024-05-09
• Last updated: 2026-01-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study