The objective of this study is to evaluate the efficacy of PROPEL Contour Sinus Implant placement in the frontal sinus ostia following dilation in patients with chronic rhinosinusitis (CRS)
A prospective, randomized, single-blind (blinded Independent Reviewer), intra-patient controlled, multicenter post-market study with 80 randomized subjects at up to 15 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.
| Condition | Chronic Rhinosinusitis, Chronic Sinusitis |
|---|---|
| Treatment | PROPEL Contour Sinus Implant, Balloon Sinus Dilation Alone |
| Clinical Study Identifier | NCT04858802 |
| Sponsor | Intersect ENT |
| Last Modified on | 18 April 2022 |
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