Sinopsys® Lacrimal Stent Indicated for Sinus Irrigation
Czechia8 participantsStarted 2016-04
Plain-language summary
The primary objective is to evaluate clinical data related to the safety and performance of the Sinopsys® Lacrimal Stent.
Who can participate
Age range22 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Investigator has determined that the potential study subject has moderate to severe chronic rhino sinusitis with ethmoid involvement and has failed medical therapy prior to enrollment.
* Age ≥22 years The potential study subject meets the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS) criteria for chronic rhino sinusitis (Rosenfeld, et al, 2007)
* 12 weeks or longer of two or more o f the following signs and symptoms:
* Mucopurulent drainage (anterior, posterior or both)
* Nasal Obstruction (congestion)
* Facial pain-pressure-fullness, or
* Decreased sense of smell and Inflammation si documents by one or more of the following findings:
* Purulent (not clear) mucus or edema in the middle meatus or ethmoid region
* Polyps in nasal cavity or the middle meatus, and/or
* Radiographic imaging showing inflammation of the paranasal sinuses
* SNOT-20 total raw score ≥ 41
* Non-Contrast CT scan (coronal view) confirms depth of olfactory fossa is Keros classification 1or 2 (Gauba, Sleh, Dua, Agarwal, Ell, \& Vize, 2006)
* The potential study subject is capable of understanding and executing written informed consent (IC)
Exclusion Criteria:
* Sinus opacification score of ≤ 8 or ≥ 18 measured using the CT derived Lund-Mackay scoring system
* Isolated sinus disease evident on Non-Contrast CT scan that would unlikely to respond to target ethmoid treatment (e.g., isolated sphenoid or frontal disease).
* Polyposis scored as 3 using t…
What they're measuring
1
Demonstration of acute procedural/device success
Timeframe: 8 Weeks
2
Evaluation of Clinical Success at Week 1, 4 and 8 weeks