Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
United States300 participantsStarted 2026-03-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female, aged ≥18 years
✓. Confirmed diagnosis of CRS per the 2021 "International Consensus Statement on Allergy and Rhinology: Rhinosinusitis" definition.
✓. Radiographic evidence of bilateral ethmoid disease on CT taken 6 months or less prior to study index procedure and at least 6 months after any prior ESS or nasal surgery, polypectomy, balloon sinus dilation, etc. as applicable
✓. Has failed previous medical treatment and is an appropriate candidate for primary or revision ESS of bilateral ethmoid sinuses and bilateral frontal/frontal sinus outflow tract
✓. Willing and able to provide written informed consent
✓. Willing and able to comply with all protocol follow up visits and assessments
Exclusion criteria
✕. Nasal cavity tumor (malignant or benign)
✕. Antrochoanal polyps
✕. Previous complete middle turbinate resection
✕. Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
. History of prior lamina dehiscence or cerebrospinal fluid (CSF) leak in skull-based dehiscence
✕. Concurrent condition requiring active chemotherapy and/or immunotherapy management
✕. Subjects whose symptoms are too severe to undergo ESS (e.g., temperature \>102.5F or extra-sinus manifestations, such as orbital cellulitis; dental or facial or brain abscess; cavernous vein thrombosis; or altered mental status
✕. History of complications from prior ESS or balloon dilation procedure (e.g., CSF leak or injury to the skull base or orbital injury)