This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with chronic sinusitis (CS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
Central California Ear, Nose Thraot
Fresno, California, United States
Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)
Time frame: 30 days
Device Placement Success Rate
A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.
Time frame: At the time of procedure
Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities
Ocular safety was characterized by assessing the frequency and severity of changes from baseline in intra-ocular pressure and lens opacities. No specific pass/fail criteria we specified.
Time frame: Baseline and 30 days
Number of Sinuses With Significant Post-operative Adhesion Formation
Adhesions were graded on a 5 point categorical scale with grades 3 and 4 considered clinically significant. 0=none, 1=small/non-obstructing, 2=obstructing/easily separated, 3=dense/obstructing/difficult to separate, and 4=severe/complete adhesion to lateral nasal wall.
Time frame: 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.