The purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent.
For purposes of this clinical study, the Sinopsys Lacrimal Stent is intended to provide a means of administering saline sinus irrigation via a transcaruncular-ethmoid sinus access in patients with moderate to severe chronic rhinosinusitis with ethmoid involvement. The purpose of the administration of saline irrigation is to reduce the intensity of symptoms of chronic rhinosinusitis in this patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.
Stanford University
Stanford, California, United States
Front Range ENT
Greeley, Colorado, United States
Advanced ENT and Allergy
Louisville, Kentucky, United States
SNOT - 20
Chronic Rhinosinusitis symptoms as measured by SNOT-20 scores from baseline to 18 weeks follow-up (1, 4, 8, 12, and 18)
Time frame: 18 Weeks
Patency will be confirmed post procedure with passive flow through the SLS lumen by instilling 2-4 drops of sterile saline into the stented medial fornix and observing drainage.
Patients will be trained for self-administration of saline irrigation prior to the discharge home. Subjects will be instructed how to observe for stent patency and to report problems with flow to the Investigator.
Time frame: 18 Weeks
Safety: Incidence and occurrence of anticipated and unanticipated adverse events
Assessment of the incidence and occurrence of anticipated and unanticipated adverse events reported during the 18 weeks of the clinical study.
Time frame: 18 Weeks
Lund-MacKay CT Scores
Comparison of baseline and 12 weeks
Time frame: 12 Weeks
Lund-Kennedy Nasal Endoscopy Scores
Comparison of baseline and 12 weeks
Time frame: 12 Weeks
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