NCT07290140
Not yet recruiting
Not Applicable
A Randomized, Controlled, Blinded, Multi-Center Trial to Assess the Safety and Efficacy of Paclitaxel-Coated Sinus Balloon as an Adjunct to Endoscopic Sinus Surgery in Adult Chronic Rhinosinusitis Subjects
Airiver Medical, Inc.1 site in 1 country300 target enrollmentStarted: March 1, 2026Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Airiver Medical, Inc.
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Primary safety
Overview
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).
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
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)
- •History of primary ciliary dyskinesia
- •Oral-steroid dependent conditions such as chronic obstructive pulmonary disease (COPD) or other conditions
Outcomes
Primary Outcomes
Primary safety
Time Frame: 30 days post- index procedure
Incidence of major adverse events (MAE) through 30 days post-index treatment.
Primary efficacy endpoint
Time Frame: 6 months post-index procedure
Reduction in need for postoperative intervention in the ethmoid and /or frontal sinus within 6 months post-index procedure.
Secondary Outcomes
- Hypothesis tested clinical responder rate at 12 months(12 months)
- Hypothesis tested mean adhesion/scaring grade of sphenoid sinus at 6 months, as assessed by the independent, blinded reviewer(6 months)
Investigators
Study Sites (1)
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