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

StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Primary completion date changed from estimate of Dec 2024 to Oct 4, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2030 to Oct 4, 2029
    • Study site revised
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 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.
Trial Details
NCT Number NCT05895305
Lead Sponsor Airiver Medical, Inc.
Collaborators: Libra Medical
Conditions
(from sponsor)		 Central Airway Obstruction
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov