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NCT07290140NARecruiting

Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis

Airiver Medical, Inc.

Start Date

6/1/2026

Completion Date

3/1/2031

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).

Detailed Description

Subjects will be randomized in a 1:1 ratio for ESS with no additional treatment (control group) or ESS followed by Airiver ESSpand DCB sinus dilation of affected sinuses (treatment group) at up to 40 US based sites.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

COMBINATION_PRODUCT

Airiver ESSpand DCB

PROCEDURE

ESS

Interested in This Trial?

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Conditions

Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Locations

Excel ENT

Birmingham, Alabama 35244

United States

SENTA Clinica

San Diego, California 92108

United States

Colorado ENT & Allergy

Colorado Springs, Colorado 80923

United States

Physicians' Clinic of Iowa

Cedar Rapids, Iowa 52403

United States

Advanced ENT

Louisville, Kentucky 40220

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Charleston ENT & Allergy

Charleston, South Carolina 29406

United States

MUSC - Medical University of South Carolina

Charleston, South Carolina 29425

United States

Dallas ENT

Dallas, Texas 75244

United States

University of Virginia

Charlottesville, Virginia 22908

United States