NCT07240259

Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 0 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

Feasibility and safety of repairing tracheal and bronchial defects in infants and children using cryopreserved donor aortic patches.

Detailed description

This trial plans to use cryopreserved donor aortic tissue patches to repair and treat pediatric patients with end-stage, life-threatening or severely disabling tracheal diseases who have not responded to conventional conservative therapies or lack sufficient native tracheal tissue for tracheal defect reconstruction.

Conditions

• Trachea Diseases
• Tracheal Stenosis
• Tuberculosis; Tracheitis
• Airway Disease
• Tracheomalacia
• Tracheal Stenosis Following Tracheostomy
• Tracheal Reconstruction Surgery

Interventions

Type	Name	Description
PROCEDURE	Cryopreserved aorta	After resection of the tracheal or bronchial lesion with standard surgical techniques, the airway gap is reconstructed with a segment of human cryopreserved (-80 celsius degree) aortic allograft, which was not matched by the ABO and leukocyte antigen systems. The anastomosis is performed with standard technique for airway anastomosis.

Timeline

• Start date: 2025-06-09
• Primary completion: 2028-01-31
• Completion: 2028-01-31
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

1 site across 1 country: Taiwan