Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Entellus Medical, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects age 18 or older with chronic rhinosinusitis of the maxillary or maxillary and anterior ethmoid sinuses
A CT scan taken after maximal medical therapy (e.g., local or systemic antibiotics, topical steroids, etc.) must show one of the following:
1. Narrowing of the outflow tract of the maxillary sinus ostium or infundibulum with mucosal thickening of 2 mm or greater of the maxillary sinus antrum.
2. Evidence of maxillary sinus air/liquid level.
You may not be if
Evidence of chronic posterior ethmoid, sphenoid or frontal sinusitis
Inability to understand the study or a history of non-compliance with medical advice
Unwilling or unable to sign Informed Consent Form (ICF)
Currently enrolled in any other pre-approval investigational study (does not apply to long-term post-market studies)
History of any cognitive or mental health status that would interfere with study participation
Previous sinus surgery or intervention including sinuplasty
Pregnant women
Severe septal deviation causing obstruction of the ostiomeatal unit
History of primary ciliary dysfunction
Hemophilia
Currently undergoing or in the past 6 months had undergone chemotherapy for cancer or radiation therapy in the head or neck region
History of cystic fibrosis
Known Sampter's Triad (aspirin sensitivity, asthma, sinonasal polyposis)
Known sinonasal tumors or obstructive lesions
History of mid facial fractures or orthognathic surgery (does not include nasal fracture)
History of insulin dependent diabetes
Not able to stop anti-coagulant (e.g., warfarin) until the International Normalized Ratio(INR) is below 1.5
Not able to stop anti-platelet (e.g., clopidogrel, aspirin, etc.) for at least 14 days prior to study procedure
Not able to stop any non-steroidal anti-inflammatory medications and homeopathic medications for at least 14 days prior to the study procedure
Presence of nasal polyps that may interfere with the treatment procedure
Presence of features consistent with sinus fungal disease on CT or physical examination
