N/A
N=50
Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
Chronic Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT00912405 ↗Enrolled (actual)
50
Serious AEs
6.0%
Results posted
Apr 2015
Primary outcome: Primary: Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT) — 6 Number of Sinuses
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Steroid-Eluting Sinexus Intranasal Splint (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Intersect ENT
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT) |
6 | — |
| PRIMARY Device Placement Success Rate |
90 | — |
| SECONDARY Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities |
— | — |
| SECONDARY Number of Sinuses With Significant Post-operative Adhesion Formation |
1 | — |
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).
Eligibility Criteria
Inclusion Criteria
- Patient is 18 years of age or older
- Patient has a diagnosis of chronic sinusitis
- Patient has a clinical indication for and has consented to FESS
- Patient CT scan confirms CS diagnosis within 6 months of procedure
- CT sacn confirms presence of disease in ethmoid sinus(es)
- Planned FESS includes unilateral or bilateral total ethmoidectomy
Exclusion Criteria
- Immune deficiency (IGG subclass deficiency or IGA deficiency)
- Oral-steroid dependent COPD, asthma or other condition
- Clinical evidence of acute bacterial sinusitis
- History or diagnosis of glaucoma or ocular hypertension
- Clinical evidence or suspicion of invasive fungal sinusitis
- Evidence of disease or condition expected to compromise survival or ability to complete follow-up
- Known history of allergy or intolerance to corticosteroids
- History of insulin dependent diabetes
Data sourced from ClinicalTrials.gov (NCT00912405). 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.