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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
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.
traditional ESS treatment of diseased sinuses.
Airiver Medical
Brooklyn Park, Minnesota, United States
Primary safety
Incidence of major adverse events (MAE) through 30 days post-index treatment.
Time frame: 30 days post- index procedure
Primary efficacy endpoint
Reduction in need for postoperative intervention in the ethmoid and /or frontal sinus within 6 months post-index procedure.
Time frame: 6 months post-index procedure
Hypothesis tested clinical responder rate at 12 months
a responder is defined as a subject who has not undergone revision ESS, balloon sinus dilation, or any other procedural intervention, or received oral/systemic steroid or biologic therapy for CRS in the follow-up period, and with SNOT-22 score change from baseline (CFBL) by ≥8.9 points
Time frame: 12 months
Hypothesis tested mean adhesion/scaring grade of sphenoid sinus at 6 months, as assessed by the independent, blinded reviewer
Grading 0 to 3, the higher grade indicates significant scarring and adhesion
Time frame: 6 months
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