Not Yet RecruitingNot Applicable

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

United States200 participantsStarted 2026-03-01

Plain-language 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.

Who can participate

Age range22 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 22 years.
✓. Symptomatic de-novo or restenotic benign central airway stenosis in the subglottis, trachea, or mainstem bronchi with at least 50% narrowing, as determined by CT or bronchoscopy.
✓. In the opinion of the investigator, subject can undergo laryngoscopy/bronchoscopy under general anesthesia and has a central airway stenosis amenable to balloon dilation.
✓. For idiopathic subglottic stenoses, either de-novo or a dilation interval equal to or less than 18 months.
✓. Target benign stenosis etiologies including:
✓. Post-intubation stenosis,
✓. Idiopathic subglottic stenosis,
✓. Post-transplantation stenosis,

What they're measuring

Primary Safety: defined as Incidence of device- and/or procedure-related Major Adverse Events(MAEs)

Timeframe: 30 days post index procedure

Primary Efficacy: freedom from clinically indicated target lesion re-intervention over time

Timeframe: Through the study completion, an average of 1 year

Trial details

NCT IDNCT07191860

SponsorAiriver Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-11-01

Contact for this trial

Robyn Schacherer, RN

6123108755 schachererr@airiver.com

View on ClinicalTrials.gov More Adult Subjects With Symptomatic Benign Airway Obstruction trials