Sinopsys Lacrimal Stent Indicated for Sinus Irrigation

Completed · Early Phase 1

Conditions studied: Ethmoid Sinusitis

In brief

The purpose of this study is to collect preliminary clinical data related to the safety and performance of the Sinopsys Lacrimal Stent.

Key facts

Study ID

NCT02297243

Run by

Sinopsys Surgical

People needed

9

Starts

2015-03-01

Expected to finish

2016-02-01

Last updated by the study team

2016-02-12

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States
• Front Range ENT — Greeley, Colorado, United States
• Advanced ENT and Allergy — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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