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RECRUITING
NCT07290140
NA

Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

Sponsor: Airiver Medical, Inc.

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-06-01

Completion Date

2031-03-01

Last Updated

2026-06-22

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Airiver 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.

PROCEDURE

ESS

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