NCT05895305

Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis

Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1 Trial)

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Airiver Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Obstruction (OXYGEN-1) is to evaluate clinical safety and potential efficacy of the Airiver Pulmonary DCB in the treatment of benign central airway stenosis.

Detailed description

Benign central airway stenosis/obstruction, including stenosis of the subglottic area, trachea, and bronchi, is related to significant morbidity due to dyspnea and impaired quality of life. It is hypothesized that Airiver pulmonary drug-coated balloon (DCB) will improve patient outcome in the bronchoscopic treatment of benign airway obstruction, and, as an adjunct to standard of care, will prolong airway patency compared to the standard of care alone. This is a prospective, multi-center, single-arm, open-label, safety \& feasibility, OUS first in human study for safety and potential efficacy.

Conditions

• Central Airway Obstruction

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Paclitaxel-Coated Pulmonary Balloon Catheter	Subjects with benign airway stenosis will be treated by Airiver pulmonary DCB at index procedure

Timeline

• Start date: 2023-05-16
• Primary completion: 2025-10-04
• Completion: 2029-10-04
• First posted: 2023-06-08
• Last updated: 2025-12-15

Locations

1 site across 1 country: Georgia