Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
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 Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis|
- Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Device Placement Success Rate [ Time Frame: At the time of procedure ] [ Designated as safety issue: No ]A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.
- Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities [ Time Frame: Baseline and 30 days ] [ Designated as safety issue: Yes ]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.
- Number of Sinuses With Significant Post-operative Adhesion Formation [ Time Frame: 30 days ] [ Designated as safety issue: No ]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.
|Study Start Date:||March 2009|
|Study Completion Date:||December 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Sinexus Intranasal Splint
Patient receives a drug-coated intranasal splint
Device: Steroid-Eluting Sinexus Intranasal Splint
Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)
Please refer to this study by its ClinicalTrials.gov identifier: NCT00912405
|United States, California|
|Central California Ear, Nose Thraot|
|Fresno, California, United States|