Status:
COMPLETED
A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
Lead Sponsor:
Intersect ENT
Conditions:
Chronic Sinusitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 Rhinosinusiti...
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-p...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00840970
Start Date
March 1 2008
End Date
April 1 2009
Last Update
October 1 2020
Active Locations (1)
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1
Central California Ear, Nose, Throat
Fresno, California, United States, 93720