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

Completed · Not applicable

Conditions studied: Chronic Sinusitis

In brief

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.

Key facts

Study ID

NCT00840970

Run by

Intersect ENT

People needed

50

Starts

2008-03-01

Expected to finish

2009-04-01

Last updated by the study team

2020-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is 18 years of age or older.
• Patient has a diagnosis of bilateral CRS defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 12 consecutive weeks' duration.
• Patient has a clinical indication for and has consented to bilateral FESS.
• CRS diagnosis documented by CT scan within 60 days of the procedure.
• Patient has minimal total CT stage (Lund-Mackay method) of 6.
• Patient has bilateral disease defined as minimal CT stage per side of ≥3.

You may not qualify if…

• Oral-Steroid dependent COPD, asthma or other condition.
• Immune deficiency (IGG subclass deficiency or IGA deficiency).
• Symptomatic coronary artery disease.
• Patient undergoing chemotherapy treatment.
• Morbid obesity (BMI > 40) or a BMI that, in the opinion of the physician, would compromise health and participation in the study.
• Evidence of active infection.

Where it is running

• Central California Ear, Nose, Throat — Fresno, California, United States

Full record on ClinicalTrials.gov

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