This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus ostia.
This is a prospective, single-center, single-arm, open label feasibility study aiming to enroll at least 10 patients and a maximum of 15 patients to achieve 30 treated sinuses. The objective of this feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis (CS) patients undergoing sinus surgery of peripheral sinus ostia.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
15
Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
South Florida ENT Associates
Miami, Florida, United States
Ohio Sinus Institute
Dublin, Ohio, United States
Device Placement Success Rate
Defined as successful access to and placement of the Propel Nova Sinus Implant in the frontal or maxillary sinus ostium within two attempts. Calculated as a proportion where the numerator is the number of successful device placements and the denominator is the number of attempted sinuses.
Time frame: Baseline Procedure
Ostial Patency
Ostial patency grading scale from 0 (patent) to 1 (Occluded/Restenosed)
Time frame: Baseline, Day 30, Day 90
Adhesion/Scarring Grade 2 & 3
Adhesion/scarring grading scale from 0 (No visible granulation/scarring), 1 (Minimal amount of scarring/contraction observed but non-obstructing the frontal or maxillary sinus ostium), 2 (moderate amount of obstructive scar tissue/contraction present in the frontal or maxillary sinus ostium), 3 (Significant scar tissue/ contraction causing obstruction of the frontal or maxillary sinus ostium)
Time frame: Baseline, Day 30, Day 90
Degree of Inflammation
Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)
Time frame: Baseline, Day 30, Day 90
Sino-Nasal Outcome Test (SNOT) 22
Validated, disease-specific, symptom-scoring instrument consisting of 22 questions, each scored by the patient on a scale of 0 (no problem) to 5 (problem as bad as it can be), resulting in a maximum total score of 110
Time frame: Baseline, Day 30, Day 90
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.