NCT07290140 Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
| NCT ID | NCT07290140 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Airiver Medical, Inc. |
| Condition | Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2028-03-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2026-06-01 with a primary completion date of 2028-03-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Noem Cohen, MD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT07290140 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07290140 currently recruiting?
Yes, NCT07290140 is actively recruiting participants. Contact the research team at myersj@airiver.com for enrollment information.
Where is the NCT07290140 trial being conducted?
This trial is being conducted at Birmingham, United States, San Diego, United States, Colorado Springs, United States, Cedar Rapids, United States and 6 additional locations.
Who is sponsoring the NCT07290140 clinical trial?
NCT07290140 is sponsored by Airiver Medical, Inc.. The principal investigator is Noem Cohen, MD at University of Pennsylvania. The trial plans to enroll 300 participants.