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Clinical Trial 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.


Clinical Trial Description

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


Study Design


Related Conditions & MeSH terms


NCT number NCT06406452
Study type Interventional
Source University of Michigan
Contact Andrea Les, PhD
Phone 734-998-5585
Email asles@umich.edu
Status Not yet recruiting
Phase N/A
Start date May 2024
Completion date November 2033

See also
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Completed NCT00536315 - Tracheal Mechanics During Bronchoscopy N/A
Recruiting NCT06072872 - Portable Continuous Positive Airways Pressure (CPAP) in Excessive Central Airway Collapse (ECAC) Study N/A
Completed NCT00705848 - Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis N/A
Completed NCT00550602 - Tracheobronchomalacia: Treatment Outcomes N/A
Enrolling by invitation NCT02982876 - Airway Stents for Excessive Dynamic Airway Collapse N/A
Completed NCT04169282 - PEEP Mask for Tracheobronchomalacia-Induced Cough N/A
Completed NCT01679808 - Pressure Dependent Tracheal Obstruction in Copd Patients N/A
Recruiting NCT05299008 - The Effect of Bethanechol on Tracheobronchomalacia
Recruiting NCT01389531 - Efficacy and Safety Evaluation of HCPA-1 Silicone Stent in the Treatment of Central Airway Obstructions N/A