N/A
N=50
A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
Chronic Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT00840970 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Device Success Rate — 14; 76; 10 ethmoid sinuses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- non-coated Intranasal Splint (Device); Sinexus Intranasal Splint (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intersect ENT
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Device Success Rate |
14; 76; 10 | — |
| PRIMARY Reduction in Ethmoid Sinus Inflammation |
23.2; 35.3 | — |
| SECONDARY Middle Turbinate Lateralization |
2; 6 | — |
| SECONDARY Middle Meatus Patency |
37; 32 | — |
| SECONDARY Significant Adhesion Occurrence |
2; 8 | — |
| SECONDARY Polypoid Tissue Changes |
7; 14 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00840970). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.