Trials / Not Yet Recruiting
Not Yet RecruitingNCT07191860
Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Central Airway Stenosis
A Randomized, Controlled, Multi-Center, Prospective Trial of Paclitaxel-Coated Pulmonary Balloon for the Treatment of Benign Airway Stenosis (OXYGEN-RCT Trial)
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Airiver Medical, Inc. · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
- Adult Subjects With Symptomatic Benign Airway Obstruction
- Adult Benign Central Airway Stenosis
- Adult Tracheobronchial Stenosis
- Tracheal Stenosis
- Central Airway Stenosis
- Central Airway Obstruction
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | The Airiver Pulmonary drug-coated balloon (DCB) dilation | drug coated balloon dilation |
| DEVICE | Commercial airway balloon dilation | uncoated airway balloon dilation |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2027-11-01
- Completion
- 2030-11-01
- First posted
- 2025-09-25
- Last updated
- 2026-03-24
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07191860. Inclusion in this directory is not an endorsement.