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.
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
At a glance
Conditions
Where it's being run
10 sites across 9 statesStudy leadership
- Noem Cohen, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.