Balloon REmodeling Antrostomy THErapy Study

Balloon REmodeling Antrostomy THErapy Study (BREATHE I)

This study is designed to evaluate safety and effectiveness of a less invasive procedure to treat maxillary only, or maxillary and anterior ethmoid, chronic sinusitis. Additionally, this study will assess the feasibility of performing the procedure under local anesthesia.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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