Sinopsys® Lacrimal Stent Indicated for Sinus Irrigation
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|ClinicalTrials.gov Identifier: NCT03304951|
Recruitment Status : Completed
First Posted : October 9, 2017
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ethmoid Sinusitis||Device: Sinopsys® Lacrimal Stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Observational Study of the Sinopsys® Lacrimal Stent in Patients With Moderate to Severe Chronic Rhinosinusitis to Evaluate Safety and Performance for Direct Ethmoid Sinus Saline Irrigation and Ophthalmic Antibiotic/Steroid Delivery|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||August 2016|
|Actual Study Completion Date :||August 2016|
Experimental: Synopsis® Lacrimal Stent
The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid sinus access
Device: Sinopsys® Lacrimal Stent
The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid access.
Other Name: SLS (Sinopsys® Lacrimal Stent)
- Demonstration of acute procedural/device success [ Time Frame: 8 Weeks ]Success defined as successful placement of the Sinopsys® Lacrimal Stent and ability to create and maintain transcaruncular access to the ethmoid sinus with the Sinopsys® Lacrimal Stent for 8 weeks post procedure.
- Evaluation of Clinical Success at Week 1, 4 and 8 weeks [ Time Frame: 8 Weeks ]Using sterile saline eye drop irrigation and two 10-Day courses of ophthalmic antibiotic/steroid eye drops, defined as improvement in SNOT (Sino-Nasal Outcome Test)-20 compared to baseline.
- Compare performance of Screening, 4, and 8 week follow up Modified Lund Kennedy nasal endoscopy scores [ Time Frame: 8 Weeks ]Comparison of Endoscopy and CT scores from Baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03304951
|Charles University Faculty of Medicine|
|Pilsen, Czechia, 30599|
|Principal Investigator:||Vladan Hrabe, MD||Charles University, Pilsen Czech Republic|