clinical trial · NCT06406452
Bioresorbable Airway Splint Pivotal Clinical Trial
University of Michigan·N/A·recruiting·n = 35
TracheobronchomalaciaBioresorbable Tracheobronchial Splint
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.
started
Jan 7, 2025
primary completion
Sep 1, 2029
completion
Mar 1, 2034
last updated
Jan 21, 2026
detailed description
Other sites will be added to the registration as sites are on-boarded.
official title
A Multi-Center Trial to Assess the Safety and Effectiveness of a Bioresorbable Tracheobronchial Splint in Pediatric Subjects With Clinically Significant Tracheobronchomalacia
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol