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

NCT07191860 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-24

No results posted yet for this study

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.

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

COMBINATION_PRODUCT

The Airiver Pulmonary drug-coated balloon (DCB) dilation

drug coated balloon dilation

DEVICE

Commercial airway balloon dilation

uncoated airway balloon dilation

Sponsors & Collaborators

  • Airiver Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Alexander Hillel, MD · Johns Hopkins University

  • Ryan M Kern, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-11-01
Completion
2030-11-01
FDA Device
Yes

Countries

  • United States

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 NCT07191860 on ClinicalTrials.gov