Clinical Trial

Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

Study acronym: RESTORE-2 RCT
Recruiting
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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).
Protocol Amendment History 1 change
notable Trial sites expanded: 1 -> 8 locations 2026-06-23
Trial Details
NCT Number NCT07290140
Lead Sponsor Airiver Medical, Inc.
Conditions Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Enrollment 300 participants
Start Date 2026-06-01
Primary Completion 2028-03-28 (estimated)
Study Completion 2031-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-30