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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Airiver Medical, Inc.
Study ID
NCT07191860
Status
Not Yet Recruiting

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Conditions

  • Adult Benign Central Airway Stenosis
  • Adult Subjects With Symptomatic Benign Airway Obstruction
  • Adult Tracheobronchial Stenosis
  • Central Airway Obstruction
  • Central Airway Stenosis
  • Tracheal Stenosis

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • The Airiver Pulmonary drug-coated balloon (DCB) dilation — COMBINATION_PRODUCT
    drug coated balloon dilation
  • Commercial airway balloon dilation — DEVICE
    uncoated airway balloon dilation

Study Details

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.

Key Dates

Start date
Mar 1, 2026
Status verified
Dec 2025
Primary completion
Nov 1, 2027
Completion
Nov 1, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: treatment with the Airiver Pulmonary DCB
    dilate benign stenoses of the airway tree.
  • Active Comparator: treatment of Commercial airway dilation balloon
    dilate benign stenoses of the airway tree.

Primary Outcome Measure

Primary Safety: defined as Incidence of device- and/or procedure-related Major Adverse Events(MAEs) [ Time Frame: 30 days post index procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21218
Clinical Operation Director
[email protected]
6123108755

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University· Baltimore, MD

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