Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

Ki vehet részt

• 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
• Radiographic evidence of bilateral frontal sinus and/or frontal sinus outflow tract disease
• Baseline SNOT-22 score ≥ 30
• 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

Ki nem vehet részt

• Previous complete middle turbinate resection
• History of prior lamina dehiscence or cerebrospinal fluid (CSF) leak in skull-based dehiscence
• Concurrent condition requiring active chemotherapy and/or immunotherapy management
• History of complications from prior ESS or balloon dilation procedure (e.g., CSF leak or injury to the skull base or orbital injury)
• Acute purulent nasal infection or upper respiratory tract infection, including but not limited to acute bacterial rhinosinusitis (ABRS), acute rhinosinusitis (ARS), or COVID -19 within 2 weeks before the baseline visit
• Subject has taken biologic drugs in the 6 months leading up to the screening visit or who expect to take biologics in the next 24 months
• Subject has taken oral corticosteroids in the 30 days leading up to their baseline appointment
• Concurrent medical condition that would affect the investigator's ability to evaluate the subject's condition or that could compromise subject safety, such as severe COPD, severe asthma
• Subject who has undergone a nasal/sinus surgery including but not limited to ESS, polypectomy, septoplasty, turbinoplasty, balloon sinus dilation, placement of steroid releasing implants, posterior nasal nerve ablation in the 6 months prior to the baseline appointment
• Previous Draf III frontal sinus surgery or a study index procedure ESS is expected to be or is a Draf III sinus surgery
• Subject whose expected study index procedure includes steroid releasing implants or non-resorbable nasal packing/stents
• Nasal cavity tumor (malignant or benign)
• 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 primary ciliary dyskinesia
• Oral-steroid dependent conditions such as chronic obstructive pulmonary disease (COPD) or other conditions
• Have evidence of significant baseline mucosal injury, ulceration, or erosion (e.g., exposed cartilage, perforation) on nasal examination
• Allergy or hypersensitivity to paclitaxel or structurally related compounds
• Subject has a history of inability to tolerate nasal endoscopy
• Life expectancy <2 years
• Antrochoanal polyps
• Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue)
• Subject who plans to undergo posterior nasal nerve ablation in the next 24 months
• Pregnant or planning to become pregnant during the first 12 months of enrollment in the study
• Subject whose index procedure did not include bilateral ethmoid ESS and bilateral frontal ESS
• Subject whose study index procedure is aborted for any reason