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Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

NCT07290140 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-12-18

No results posted yet for this study

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).

Conditions

  • Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Interventions

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.

Sponsors & Collaborators

  • Airiver Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Noem Cohen, MD · University of Pennsylvania

  • Rodney Schlosser, MD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2028-03-28
Completion
2031-03-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07290140 on ClinicalTrials.gov