| Eligibility |
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 in?ammation 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 study subject is capable of understanding and executing written informed
consent (IC) and questionnaires/diaries in English
Exclusion Criteria:
- Sinus opacification score of <10 or > 41 measured using the Zinreich Modified CT
scoring system
- Isolated sinus disease evident on Non-Contrast CT scan that would be unlikely to
respond to target ethmoid treatment (e.g., isolated sphenoid, maxillary or frontal
disease)
- Polyposis scored as 2 using the Modified Lund-Kennedy Score
- Prior ocular and/or sinus surgery that alter the boney anatomy or violate/enter the
orbit or sinus in a way that would render these structures "non-intact" (i.e. FESS).
Minor procedures such as balloon sinus dilation (>30 days), septoplasty or
turbinectomy are not exclusions.
- Non-Contrast CT scan (coronal view) shows depth of olfactory fossa is Keros
classification type 3
- Prior surgical history, physical exam, nasal endoscopy and/or imaging studies that
suggest significant craniofacial deformity (such as any facial anatomic abnormality
from surgical intervention, trauma, and congenital or any other cause thus prohibiting
adequate placement of the Sinopsys Lacrimal Stent
- Presence of a sinonasal encepholocele as determined by Non-Contrast CT scan
- Presence of active HEENT infection including acute dacryocystitis, with the exception
of CRS infection
- Febrile illness within 2 weeks of procedure and/or active pus from nose
- Any sign of active ophthalmic disease, infection, or inflammation including the
presence of severe ocular surface inflammatory disease as determined by ophthalmic and
physical exam, which could be exacerbated by the presence of the device
- Best Corrected Visual Acuity (BCVA) worse than 20/50
- Dry Eye disease defined by the following:
- Abnormal Tear Breakup Test (TBUT) (< 5 seconds) in either eye and
- Corneal staining showing superficial punctate keratopathy of Grade 1 or higher in
either eye at Screening Visit
- Use of topical or systemic prescription ocular medications, except rewetting drops for
contact lens-related discomfort, for the eye to treat an active ophthalmic disease at
or within 14 days of screening and through procedure
- Underlying medical condition that, in the opinion of the Investigator, would place the
subject at high risk if IV sedation (MAC or monitored anesthesia care) were used
during the procedure
- Excessive ocular and/or adipose tissue that may obscure implanted device visualization
and/or placement
- Known allergies to silicone, TobraDex® (Tobramycin and Dexamethasone), procedural
medications, and ophthalmic eye drops (required for routine eye exams)
- Documented diagnostic history of Cystic Fibrosis
- Documented history of migraines, cluster headaches, chronic daily headaches or other
headaches unrelated to the sinus
- Documented uncontrolled or poorly controlled seasonal or perennial allergies
- Requires any amount of concurrent systemic steroid medication for chronic illness such
as auto-immune diseases
- Tobacco, marijuana and/or e-vape inhaler use either currently or during the last 90
days
- Documented history of bleeding disorders, for example, von Willebrand's disease or
hemophilia
- Inability to stop thrombolytics or other anti-platelet medication prior to procedure
day including but not limited to Coumadin (warfarin) for 5 days, Plavix (clopidogrel)
for 3 days, ASA/NSAIDs/fish oil supplements for 10 days, Xarelto® (rivaroxaban) for 24
hours
- For contact lens wearers, inability to go without contact lenses for at least 10 days
postoperatively
- Known use of any investigational ocular or sinus drug(s) or devices within 30 days
prior to enrollment
- Investigator determination that the potential study subject is unable to comply with
study procedures and/or follow-up, or provide informed consent
- Women of childbearing potential who test positive on the study-required urine
pregnancy test or who are unwilling to practice a medically acceptable contraception
regimen from Screening Visit though Week 12 visit. Women who are documented as
postmenopausal for at least 1 year (> 12 months since last menses) or are surgically
sterilized do not require testing
- Severe co-morbidity or poor general physical/mental health that, in the opinion of the
Investigator, will not allow the subject to be a good study candidate (i.e. other
disease processes, mental capacity, cognitive function, substance abuse, shortened
life expectancy, vulnerable patient population, high surgical risk)
- Currently involved in another clinical study where that participation may conflict or
interfere with the treatment, follow-up or results of this clinical study
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