Safety and Performance of a Bioabsorbable Fluticasone Propionate-eluting sinus dressing (SinuBand) in the Postoperative management of Functional Endoscopic Sinus Surgery in patients with Chronic Rhinosinusitis
- Conditions
- chronic rhinosinusitisnasal polyps1004630410038737
- Registration Number
- NL-OMON38446
- Lead Sponsor
- BioInspire Technologies
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Patients aged >18 years, with chronic rhinosinusitis (with nasal polyps), in whom bilateral endoscopic endonasal anterior and posterior ethmoidectomy is indicated due to failure of medical treatment, whether as first surgical approach or as revision surgery.
Patients with a known history of corticosteroid (CS) intolerance will be excluded from the study, as well as those dependent on oral CS or with a history of immunodeficiency, fungal rhinosinusitis, previous nasal polyp surgery in which the middle turbinates have been removed on one or both sides, severe asthma, glaucoma, cataract, or insulin-dependent diabetes mellitus. Patients with known hypersensitivity to any component of SinuBand will be excluded from the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Local sinus safety will be assessed by monitoring for device-related adverse<br /><br>events.<br /><br>Ocular safety will be characterized via baseline and follow-up (day 15 and 30)<br /><br>measurement of intraocular pressure (IOP) and examination for lens opacities.<br /><br>Systemic safety will be evaluated through the measure of the cortisol in 24h<br /><br>urine collection at day minus 1 and at day 15.<br /><br>.<br /><br>.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Reduction in ethmoid inflammation (graded in a visual analog scale 0 to 100 mm)<br /><br>at any time during follow up (±2) 5, 15, 30 and 60 days) in the SinuBand FP arm<br /><br>compare to the controls.<br /><br>Synechiae and postoperative intervention as surgical intervention to separate<br /><br>an adhesion or oral steroid intervention for recurrent ethmoid inflammation<br /><br>edema and /or polyp recurrence at 30 days will also be measured.<br /><br>The secondary outcome measures will be evaluated from video-endoscopies<br /><br>reviewed by blinded independent panel of 3 ENT surgeons</p><br>