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Clinical Trials in the USA / NCT07290140
Recruiting Not applicable

Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

NCT07290140 · tracked via the Priya Life Science USA tracker
Sponsor
Airiver Medical, Inc.
Phase
Not applicable
Started
2026-06-01
Last updated
2026-07-30

Condition(s) studied

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Investigational drug(s) / intervention(s)

Airiver ESSpand DCBESS

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.

ESS: traditional ESS treatment of diseased sinuses.

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Male or female, aged ≥18 years 2. Confirmed diagnosis of CRS per the 2021 "International Consensus Statement on Allergy and Rhinology: Rhinosinusitis" definition. 3. 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 4. Radiographic evidence of bilateral frontal sinus and/or frontal sinus outflow tract disease 5. Baseline SNOT-22 score ≥ 30 6. 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 7. Willing and able to provide written informed consent 8. Willing and able to comply with all protocol follow up visits and assessments Exclusion Criteria: 1. Nasal cavity tumor (malignant or benign) 2. Antrochoanal polyps 3. Previous complete middle turbinate resection 4. Clinical evidence or suspicion of invasive fungal sinusitis (e.g., bone erosion on CT scan, necrotic sinus tissue) 5. History of prior lamina dehiscence or cerebrospinal fluid (CSF) leak in skull-based dehiscence 6. Concurrent condition requiring active chemotherapy and/or immunotherapy management 7. 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 8. History of complications from prior ESS or balloon dilation procedure (e.g., CSF leak or injury to the skull base or orbital injury) 9. History of primary ciliary dyskinesia 10. Oral-steroid dependent conditions such as chronic obstructive pulmonary disease (COPD) or other conditions 11. Have evidence of significant baseline mucosal injury, ulceration, or erosion (e.g., exposed cartilage, perforation) on nasal examination 12. 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. 13. Allergy or hypersensitivity to paclitaxel or structurally related compounds. 14. 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. 15. Subject has taken oral corticosteroids in the 30 days leading up to their baseline appointment. 16. Subject who plans to undergo posterior nasal nerve ablation in the next 24 months. 17. Subject has a history of inability to tolerate nasal endoscopy 18. 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 19. Pregnant or planning to become pregnant during the first 12 months of enrollment in the study 20. 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. 21. Previous Draf III frontal sinus surgery or a study index procedure ESS is expected to be or is a Draf III sinus surgery. 22. Subject whose index procedure did not include bilateral ethmoid ESS and bilateral frontal ESS 23. Subject whose expected study index procedure includes steroid releasing implants or non-resorbable nasal packing/stents. 24. Subject whose study index procedure is aborted for any reason 25. Life expectancy \<2 years

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
Excel ENT Birmingham Alabama Recruiting
SENTA Clinica San Diego California Recruiting
Colorado ENT & Allergy Colorado Springs Colorado Recruiting
Physicians' Clinic of Iowa Cedar Rapids Iowa Recruiting
Advanced ENT Louisville Kentucky Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
Charleston ENT & Allergy Charleston South Carolina Recruiting
MUSC - Medical University of South Carolina Charleston South Carolina Recruiting
Dallas ENT Dallas Texas Recruiting
University of Virginia Charlottesville Virginia Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07290140 on ClinicalTrials.gov ↗ ← All trials in the USA