The ENCORE Study is designed to evaluate the repeat administration of the S8 Sinus Implant in chronic sinusitis (CS) patients with recurrent nasal polyps.
The ENCORE Study is a prospective open-label, non-randomized, multicenter study in CS patients who had undergone prior endoscopic sinus surgery (ESS) including bilateral total ethmoidectomy and present with bilateral ethmoid polyposis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Sacramento ENT
Sacramento, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
DuPage Medical Group
Naperville, Illinois, United States
Advanced ENT & Allergy
Number of Participants With Implant-Related Serious Adverse Events
Evaluated via tabulation of implant-related serious adverse events (SAE) reported by subjects between consent and Day 365.
Time frame: 365 days
SNOT-22 Total Score
Sino-Nasal Outcomes Test (SNOT-22) is a validated disease-specific symptom-scoring instrument consisting of 22 questions, each scored on a 6-point scale of 0 (no problem) to 5 (probably as bad as it can be) based on the subject's recollection of symptoms over the past 2 weeks. The total score ranges from 0 to 110, with a higher score reflecting greater symptom burden. Change from baseline to 90 days and to 180 days is calculated as the value at 90/180 days minus the value from baseline. Negative values for change from baseline indicate reduction (improvement) in sino-nasal symptoms.
Time frame: Baseline, 90 days, 180 days
Nasal Obstruction/Congestion Score
Determined on a scale of 0 (no symptoms) to 3 (severe symptoms) based on the subject's recollection of symptoms over the past week using a reflective paper questionnaire. Change from baseline to 90 days and to 180 days is calculated as the value at 90/180 days minus the value at baseline. Negative values for change from baseline to follow-up indicate reduction (improvement) in nasal obstruction/congestion.
Time frame: Baseline, 90 days, 180 days
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Louisville, Kentucky, United States
Associated Surgical Specialists
Covington, Louisiana, United States
BreatheAmerica of Albuquerque
Albuquerque, New Mexico, United States
Madison ENT
New York, New York, United States
Charlotte Eye, Ear, Nose and Throat Associates
Concord, North Carolina, United States
Bridgerland Clinical Research
North Logan, Utah, United States