Paclitaxel-Coated Balloon Treatment for Chronic Rhinosinusitis

This study is looking at a new way to treat chronic rhinosinusitis (CRS), a long-lasting inflammation of the sinuses, in adults. It's testing a procedure called Airiver ESSpand DCB, which uses a balloon coated with paclitaxel (a medication) to open up the sinuses after traditional endoscopic sinus surgery (ESS). The study wants to see if this combination treatment is safe after 30 days and how well it works after 6 months. You might be able to join if you are 18 or older, have a confirmed diagnosis of CRS with or without nasal polyps, and need endoscopic sinus surgery. The study is currently recruiting 300 participants.

Study design
This is a randomized, controlled, double-blind study involving 300 participants. Participants will either receive traditional ESS or ESS followed by the Airiver ESSpand DCB procedure.
What's involved
All participants will undergo traditional endoscopic sinus surgery (ESS). Some will also have the Airiver ESSpand DCB procedure. Safety will be checked at 30 days, and effectiveness at 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety for 30 days and for efficacy for 6 months after their procedure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07290140

Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

Recruiting
NAAges 18+InterventionalTreatment
Airiver Medical, Inc.
~300 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Airiver ESSpand DCBESS

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary safety
Measured over 30 days post- index procedure
+1 more outcome measured
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
10 sites across 9 states
South Carolina2
Alabama1
California1
Colorado1
Iowa1
Kentucky1
Pennsylvania1
Texas1
  • Noem Cohen, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

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  • Primary safety30 days post- index procedure

    Incidence of major adverse events (MAE) through 30 days post-index treatment.

  • Primary efficacy endpoint6 months post-index procedure

    Reduction in need for postoperative intervention in the ethmoid and /or frontal sinus within 6 months post-index procedure.