Balloon REmodeling Antrostomy THErapy Study
Condition: Sinusitis
MeSH terms: Sinusitis
Intervention: RS-Series Rhinosinusitis Treatment System; FinESS Balloon
Intervention description: Single arm
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic rhinosinusitis; Chronic sinusitis; Maxillary sinus; Anterior ethmoid sinus; Ethmoid infundibulum; Balloon dilation; Endoscopic visualization; Local anesthesia; Canine fossa; Less invasive

Summary:

      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.
    

Eligibility criteria:

        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