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

NCT ID: NCT00912405

Last Updated: 2015-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-12-31

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).

Conditions

Chronic Sinusitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Sinexus Intranasal Splint

Patient receives a drug-coated intranasal splint

Group Type: EXPERIMENTAL

Steroid-Eluting Sinexus Intranasal Splint

Intervention Type: DEVICE

Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

Interventions

Steroid-Eluting Sinexus Intranasal Splint

Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intersect ENT

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Central California Ear, Nose Thraot

Fresno, California, United States

Countries

United States

Other Identifiers

P500-0209

Identifier Type: -

Identifier Source: org_study_id