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Paclitaxel-Coated Balloon for Narrowing of the Airway

(OXYGEN-RCT Trial)

ME
RS
Overseen ByRobyn Schacherer, RN
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Airiver Medical, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

RM

Ryan M Kern, MD

Principal Investigator

Mayo Clinic

AH

Alexander Hillel, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 22 years old or older.
I have severe narrowing in my airways due to a non-cancerous condition.
My doctor believes I can safely have a throat or lung scope under anesthesia to widen my airway.
See 7 more

What Are the Treatments Tested in This Trial?

Interventions

  • Paclitaxel-Coated Pulmonary Balloon

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: treatment with the Airiver Pulmonary DCBExperimental Treatment1 Intervention
Group II: treatment of Commercial airway dilation balloonActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Airiver Medical, Inc.

Lead Sponsor

Trials
2
Recruited
90+

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