NCT05883462

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

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Airiver Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Rhinosinusitis

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Airiver Nasal Drug Coated Balloon (DCB) Catheter.	The balloon is coated with a paclitaxel drug (3.5ug/mm2).

Timeline

• Start date: 2023-06-07
• Primary completion: 2025-10-21
• Completion: 2029-12-30
• First posted: 2023-06-01
• Last updated: 2025-12-15

Locations

1 site across 1 country: Paraguay