RecruitingNot ApplicableNCT07290140

Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

A Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Safety and Efficacy of Paclitaxel-Coated Sinus Balloon as an Adjunct to Endoscopic Sinus Surgery in Adult Chronic Rhinosinusitis Subjects


Sponsor

Airiver Medical, Inc.

Enrollment

300 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, multicenter, randomized, controlled, double-blind clinical trial enrolling 300 adult subjects with chronic rhinosinusitis (CRS) with and without nasal polyps (CRSwNP and CRSsNP) indicated for endoscopic sinus surgery (ESS).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Airiver ESSpand DCB and a procedure called ESS for people with chronic rhinosinusitis (crs) with and without nasal polyps. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTAiriver ESSpand DCB

The investigational procedure will be ESSpand DCB dilation of all surgically treated sinuses, including the resected ethmoid sinus cavities. Note: Prior to randomization to the investigational procedure, all subjects will undergo traditional ESS of their diseased sinuses.

PROCEDUREESS

traditional ESS treatment of diseased sinuses.


Locations(8)

Excel ENT

Birmingham, Alabama, United States

SENTA Clinica

San Diego, California, United States

Colorado ENT & Allergy

Colorado Springs, Colorado, United States

Physicians' Clinic of Iowa

Cedar Rapids, Iowa, United States

Advanced ENT

Louisville, Kentucky, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Dallas ENT

Dallas, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07290140


Related Trials