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Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH)

Chronic Rhinosinusitis Clinical Trial

Official title:
Prospective Trial of Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps

Clinical Trial Summary

It is a first in human (FIH) study to evaluate safety, and potential efficacy of Airiver Nasal DCB in the treatment of recurrent CRSwNP or CRSsNP. Participants will receive AIRIVER Nasal drug-coated balloon treatment.

Clinical Trial Description

Paclitaxel coated balloon is designed to offer both mechanical dilation of nasal obstruction and local drug effect for underlying inflammatory disorder and cell hyperplasia. It is hypothesized that Airiver Nasal drug-coated balloon (DCB) will improve patient outcome and as an adjunct to standard of care, will improve nasal patency than the standard of care alone. This is a prospective, single arm, first in human (FIH) study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05883462
Study type Interventional
Source Airiver Medical, Inc.
Contact Yan Li, MD
Phone 6513530685
Email liy@airiver.com
Status Recruiting
Phase Early Phase 1
Start date June 7, 2023
Completion date December 2029
View Details
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