Status:
COMPLETED
Sinopsys Lacrimal Stent Indicated for Sinus Irrigation
Lead Sponsor:
Sinopsys Surgical
Conditions:
Ethmoid Sinusitis
Eligibility:
All Genders
22+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent.
Detailed Description
For purposes of this clinical study, the Sinopsys Lacrimal Stent is intended to provide a means of administering saline sinus irrigation via a transcaruncular-ethmoid sinus access in patients with mod...
Eligibility Criteria
Inclusion
- The Investigator has determined that the potential study subject has moderate to severe chronic rhinosinusitis with ethmoid involvement and has followed at least twelve (12) weeks of appropriate 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 rhinosinusitis 12 weeks 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
- SNOT-20 total score ≥ 41
- CT scan (coronal view) confirms inflammation / involvement of the ethmoid sinuses
- CT scan (coronal view) confirms depth of olfactory fossa is Keros classification 1 or 2.
Exclusion
- Sinus opacification score of ≤ 8 or ≥ 18 measured using the CT derived Lund -- Mackay scoring system
- Isolated sinus disease evident on CT scan that would be unlikely to respond to target ethmoid treatment (e.g., isolated sphenoid or frontal disease)
- Severe polyposis defined as Grade III or Grade IV polyposis using the adapted scale from Meltzer, 2006.
- Prior ocular and/or sinus surgery for CRS
- CT scan (coronal view) shows depth of olfactory fossa is Keros classification 3.
- Prior surgical history, physical exam, nasal endoscopy and/or imaging studies suggest significant distortion of the craniofacial anatomy thus prohibiting adequate placement of the SLS
- Presence of a sinonasal encepholocele as determined by CT scan
- Presence of active HEENT infection including acute dacryocystitis
- Febrile illness within 2 weeks and/or active pus from nose
- Any sign of active ophthalmic disease, infection, or inflammation including the presence of severe ocular surface inflammatory disease or signs and symptoms of "dry eye disease" as determined by physical exam which could be exacerbated by the presence of the device
- Current use of topical medications for the eye to treat an active ophthalmic disease
- HbA1c level of ≥ 7.5% at the time of screening, current chemotherapy, or other immune compromised conditions
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02297243
Start Date
March 1 2015
End Date
February 1 2016
Last Update
February 12 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Stanford, California, United States, 94305
2
Front Range ENT
Greeley, Colorado, United States, 80634
3
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207