Clinical Trial

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

Active, Not Recruiting Early Phase 1
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-05-30; most recent amendment 2025-12-08.
Status change: Recruiting → Active, Not Recruiting 2025-12-08
Status change: Not Yet Recruiting → Recruiting 2023-08-21
Trial Details
NCT Number NCT05883462
Lead Sponsor Airiver Medical, Inc.
Conditions Chronic Rhinosinusitis
Enrollment 45 participants
Start Date 2023-06-07
Primary Completion 2025-10-21 (estimated)
Study Completion 2029-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-12-15