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

Study acronym: OXYGEN-RCT
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Recruitment opened
    • Start date changed from estimate of Mar 1, 2026 to Feb 24, 2026
    • Site details revised
    v4
  2. Study sites: 0 to 1
    • Start date: Feb 1, 2026 to Mar 1, 2026
    v3
  3. Start date: Nov 1, 2025 to Feb 1, 2026v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07191860
Lead Sponsor Airiver Medical, Inc.
Conditions
(from sponsor)		 Adult Subjects With Symptomatic Benign Airway Obstruction, Adult Benign Central Airway Stenosis, Adult Tracheobronchial Stenosis, Tracheal Stenosis, Central Airway Stenosis, Central Airway Obstruction
Related terms Tracheal Stenosis
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov