NCT00912405

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Intersect ENT · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Steroid-Eluting Sinexus Intranasal Splint	Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-06-01
• Completion: 2009-12-01
• First posted: 2009-06-03
• Last updated: 2015-04-20
• Results posted: 2015-04-20

Locations

1 site across 1 country: United States