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.
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).
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
- Age range
- 18+ years
- Sex
- All
- 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 approp…
Interventions
- Combination ProductAiriver 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.
- ProcedureESS
traditional ESS treatment of diseased sinuses.
Location
- Airiver MedicalBrooklyn Park, Minnesota