An Early Phase 1 interventional study of Paclitaxel-Coated Pulmonary Balloon Catheter in Central Airway Obstruction, sponsored by Airiver Medical, Inc.. Active, not recruiting at 1 site in Georgia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-15.
Sponsored by Airiver Medical, Inc. · Early Phase 1, Interventional, and Treatment
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.
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.
Airiver Medical, Inc. is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Symptomatic, severe (> 50%) benign CAO (by CT or bronchoscopy)
Includes, but not limited to :
Exclusion Criteria:
subject will be treated by Airiver Pulmonary Drug Coated Balloon (DCB) catheter. The balloon is coated with a paclitaxel drug (3.5ug/mm2).
Combination Product: Paclitaxel-Coated Pulmonary Balloon Catheter
Subjects with benign airway stenosis will be treated by Airiver pulmonary DCB at index procedure
Also known as: DCB
Primary safety: Freedom from major adverse device events (MADE) post index procedure through 30 days.
MADE is defined as: * Airway perforation (Pneumothorax) * Pneumomediastinum * Massive bleeding * Mediastinitis requiring the need for IV antibiotics and / or hospitalization * Respiratory distress or asphyxia requiring intubation or reintervention * Evidence of negative local tissue reaction to paclitaxel Subjects failing any component of the primary safety endpoint will be considered a safety failure, and subjects who remain event free through 30 days will be considered safety successes. Primary safety will be assessed as the proportion of subjects free from the primary safety event.
Time frame: 30 days
Primary efficacy: Freedom from symptom-driven target lesion reintervention (TLR) due to recurrence of stenosis through 6 months
The incidence of subjects free from symptom-driven TLR will be assessed via Kaplan-Meier survival analysis.
Time frame: 6 months
Incidence of, and time to, symptom-driven target lesion reintervention through 12 months.
assessed via Kaplan-Meier survival analysis.
Time frame: 12 months
Bronchoscopic target lesion patency (Myer-Cotton airway grading system) change through 12 months.
Grade 1 - 0-50% obstruction Grade 2 - 51-70% obstruction Grade 3 - 71-99% obstruction Grade 4 - No detectable lumen.
Time frame: 12 months
Spirometry (FEV1) change through 12 months
A spirometry will be compared at baseline vs follow-ups. Lower readings indicate more significant obstruction.
Time frame: 12 months
mMRC (Modified Medical Research Council) dyspnea scale change through 12 months
The grade range is from 0-4. Higher grades indicate worse respiratory disability.
Time frame: 12 months.
Quality of life (QOL) change: Patient report outcomes (SF-12) through 12 months
Converting SF-12 Item Responses to Physical and Mental Standardized Values. Higher scores indicate better health
Time frame: 12 months
Clinical pharmacokinetics of paclitaxel by 10 days
plasma paclitaxel concentration will be assessed per predesignated time points.
Time frame: 10 days
This study is active, not recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Airiver Medical, Inc.