NCT07290140

Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Airiver Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Subjects will be randomized in a 1:1 ratio for ESS with no additional treatment (control group) or ESS followed by Airiver ESSpand DCB sinus dilation of affected sinuses (treatment group) at up to 40 US based sites.

Conditions

• Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-03-28
• Completion: 2031-03-01
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study