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

The OXYGEN-RCT trial is a randomized, controlled, double blinded, prospective, multi-center trial to demonstrate the safety and efficacy in adult benign central airway stenosis. Participates will be in a 1:1 allocation to treatment with the Airiver Pulmonary DCB or standard of care laryngoscopic/bronchoscopic balloon dilation, respectively.

NCT Number	NCT07191860
Lead Sponsor	Airiver Medical, Inc.
Conditions	Adult Subjects With Symptomatic Benign Airway Obstruction, Adult Benign Central Airway Stenosis, Adult Tracheobronchial Stenosis, Tracheal Stenosis, Central Airway Stenosis, Central Airway Obstruction
Enrollment	200 participants
Start Date	2026-02-24
Primary Completion	2027-11-01 (estimated)
Study Completion	2030-11-01 (estimated)
Updated on ClinicalTrials.gov	2026-06-18