Sinopsys Lacrimal Stent Study for Patients With Chronic Sinusitis or CRS (NCT03066908) | Clinical Trial Compass
SuspendedNot Applicable
Sinopsys Lacrimal Stent Study for Patients With Chronic Sinusitis or CRS
Stopped: Change in study design
United States4 participantsStarted 2017-04-20
Plain-language summary
A prospective, single arm, multicenter study designed to demonstrate that the Sinopsys® Lacrimal Stent can safely create transcaruncular access to the ethmoid sinus to enable sinus irrigation and reduce symptoms in patients with moderate to severe chronic rhinosinusitis.
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The Investigator has determined that the potential study subject has moderate to severe chronic rhinosinusitis with ethmoid involvement:
* Non-Contrast CT scan (coronal view) Total Zinreich Modified CT score of 10-41
* Inflammation/ involvement of the ethmoid sinus with left and/or right anterior ethmoid and/or posterior ethmoid Zinreich Modified CT scores of 1-4
* SNOT-22 total raw score ≥ 45
* Meets the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS) criteria for chronic rhinosinusitis (CRS) (Rosenfeld, et al., 2007): 90 days or longer of two or more of 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 is documented 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
* Has failed medical therapy (Rudmik, et al., 2016) defined as the following:
During the 90 days prior to enrollment, at a minimum:
One course of broad spectrum or culture directed oral antibiotic of at least 2 weeks duration 60 days of topical intranasal steroid therapy and; 30 days of saline irrigation
* Age ≥ 22 years
* Non-Contrast CT scan (coronal view) confirms depth of olfactory fossa is Keros classification type 1 or 2
* The potential s…