NCT00840970

A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis

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

• 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

The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.

Detailed description

This was a prospective, multi-center, double blind trial that enrolled patients in three groups as described below. Two groups (Pilot 15 mm and Efficacy 25 mm) used a randomized, double-blind, intra-patient control study design to assess performance of the drug-coated Splint (received in one ethmoid sinus) compared to the control Splint (received in the contralateral ethmoid). The other group of patients (Safety/PK 25 mm) received bilateral drug-coated Splints, and served as a pharmacokinetics (PK) study group.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
DEVICE	non-coated Intranasal Splint	placement of non-coated intranasal splint following FESS
DEVICE	Sinexus Intranasal Splint	placement of Sinexus Intranasal Splint placed following FESS

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-03-01
• Completion: 2009-04-01
• First posted: 2009-02-11
• Last updated: 2020-10-01
• Results posted: 2020-10-01

Locations

1 site across 1 country: United States