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

NCT05895305 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-12-15

No results posted yet for this study

Summary

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.

Conditions

  • Central Airway Obstruction

Interventions

COMBINATION_PRODUCT

Paclitaxel-Coated Pulmonary Balloon Catheter

Subjects with benign airway stenosis will be treated by Airiver pulmonary DCB at index procedure

Sponsors & Collaborators

  • Libra Medical

    collaborator OTHER

  • Airiver Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Kakha Vacharadze, MD · National Center for Tuberculosis and Lung Diseases, Tbilisi State Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-16
Primary Completion
2025-10-04
Completion
2029-10-04

Countries

  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05895305 on ClinicalTrials.gov