Chronic Rhinosinusitis (Diagnosis) Clinical Trial
Official title:
The EXPAND Study: A Clinical Evaluation of PROPEL® Contour Sinus Implant Placement in the Frontal Sinus Ostium Following In-office Bilateral Balloon Dilation
The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)
A post-market, randomized, intra-patient controlled, blinded multicenter study with 80 randomized subjects at up to 20 study centers. After successful in-office bilateral balloon dilation of the frontal sinus ostium (FSO) using the VenSure™ Nav Balloon Device and Fiagon Cube Navigation System, patients will be randomized to receive one PROPEL Contour Sinus Implant on one side while the contralateral side serves as the control. ;
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