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Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
Sponsor: Airiver Medical, Inc.
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
2026-10-29
Healthy Volunteers
No
Interventions
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.
ESS
traditional ESS treatment of diseased sinuses.
Locations (16)
University of Alabama
Birmingham, Alabama, United States
Excel ENT
Birmingham, Alabama, United States
North Alabama ENT
Huntsville, 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
KUMC
Kansas City, Kansas, United States
Advanced ENT
Louisville, Kentucky, United States
Montefiore Medical Center
The Bronx, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Charleston ENT & Allergy
Charleston, South Carolina, United States
MUSC - Medical University of South Carolina
Charleston, South Carolina, United States
Dallas ENT
Dallas, Texas, United States
Ear and Sinus Institute
Fort Worth, Texas, United States
ENT Associates of Texas
McKinney, Texas, United States
University of Virginia
Charlottesville, Virginia, United States