clinical trial · NCT07191860
Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Central Airway Stenosis
Airiver Medical, Inc.·N/A·recruiting·n = 200
Adult Subjects With Symptomatic Benign Airway ObstructionAdult Benign Central Airway StenosisAdult Tracheobronchial StenosisTracheal StenosisCentral Airway StenosisCentral Airway ObstructionThe Airiver Pulmonary drug-coated balloon (DCB) dilationCommercial airway balloon dilation
brief summary
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.
started
Feb 24, 2026
primary completion
Nov 1, 2027
completion
Nov 1, 2030
last updated
Jun 18, 2026
detailed description
Subjects will complete follow-up post-treatment at 30 days, 3 months, 6 months, 12 months, and every 6 months after through the primary endpoint, with a minimum of 2 years at study end.
official title
A Randomized, Controlled, Multi-Center, Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis (OXYGEN-RCT Trial)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol