Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis

Not Applicable

Completed

• Conditions: Chronic Sinusitis
• Interventions: Device: Steroid-Eluting Sinexus Intranasal Splint

• Registration Number: NCT00912405
• Lead Sponsor: Intersect ENT

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2009-06
• Study First Submitted: 2009-06-01
• Study First Submitted QC: 2009-06-02
• Study First Posted: 2009-06-03
• Study Completion: 2009-12
• Results First Submitted: 2014-10-23
• Status Verified: 2015-03
• Results First Submitted QC: 2015-03-25
• Last Update Submitted: 2015-03-25
• Results First Posted: 2015-04-20
• Last Update Posted: 2015-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patient is 18 years of age or older
• Patient has a diagnosis of chronic sinusitis
• Patient has a clinical indication for and has consented to FESS
• Patient CT scan confirms CS diagnosis within 6 months of procedure
• CT sacn confirms presence of disease in ethmoid sinus(es)
• Planned FESS includes unilateral or bilateral total ethmoidectomy

Exclusion Criteria

• Immune deficiency (IGG subclass deficiency or IGA deficiency)
• Oral-steroid dependent COPD, asthma or other condition
• Clinical evidence of acute bacterial sinusitis
• History or diagnosis of glaucoma or ocular hypertension
• Clinical evidence or suspicion of invasive fungal sinusitis
• Evidence of disease or condition expected to compromise survival or ability to complete follow-up
• Known history of allergy or intolerance to corticosteroids
• History of insulin dependent diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sinexus Intranasal Splint	Steroid-Eluting Sinexus Intranasal Splint	Patient receives a drug-coated intranasal splint

Primary Outcome Measures

Name	Time	Method
Device Placement Success Rate	At the time of procedure	A proportion where the numerator is the number of successful device placements and denominator is the number of attempted sinuses.
Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)	30 days

Secondary Outcome Measures

Name	Time	Method
Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities	Baseline and 30 days	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	30 days	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.

Trial Locations

Locations (1)

Central California Ear, Nose Thraot; 🇺🇸 Fresno, California, United States