Balloon REmodeling Antrostomy THErapy Study

Study Overview
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Brief Summary
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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.

Official Title
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Balloon REmodeling Antrostomy THErapy Study (BREATHE I)

Conditions
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Sinusitis

Intervention / Treatment
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* Device: RS-Series Rhinosinusitis Treatment System
* Device: FinESS Balloon


Participation Criteria
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Eligibility Criteria
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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: 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. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Balloon Dilation<br>Balloon dilation with FinESS device | Device: RS-Series Rhinosinusitis Treatment System<br>* Single arm<br>Device: FinESS Balloon<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidences of Device-related or Procedure-related Complications |  | Through 12 months post-procedure | 
| Patency of the Treated Area as Verified by CT Scan | Post-procedure Patency was assessed using a CT scan 3 months post-procedure. The osteomeatal complex was assessed for patency by physicians. | Post-treatment at 3 months | 
| Symptomatic Score Change- Sinonasal Outcome (SNOT) 20 Score Improvement | Symptomatic change in SNOT 20 scores on a 5-point Likert scale where 0 = no problem to 5 = problem as bad as it can be were calculated. Baseline scores and 12 month post-procedure follow-up scores were calculated and compared. A score reduction of at least 0.8 (-0.8) from baseline to 12 months is considered statistically significant and clinically impactful. | Post-treatment through 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic rhinosinusitis, Chronic sinusitis, Maxillary sinus, Anterior ethmoid sinus, Ethmoid infundibulum, Balloon dilation, Endoscopic visualization, Local anesthesia, Canine fossa, Less invasive