XprESS Maxillary Balloon Dilation Study

Study Overview
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Brief Summary
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A prospective, single-arm, post approval pilot study.

Detailed Description
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This study is evaluating transnasal sinus balloon dilation without tissue removal to treat the maxillary sinuses in patients with sinusitis. The study will be assessing symptomatic improvement post procedure.

Official Title
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XprESS Maxillary Sinus Balloon Dilation Study

Conditions
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Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)

Intervention / Treatment
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* Device: Balloon sinus dilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least 18 years of age. Must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease. Meet EITHER the Anthem Coverage Guideline OR BlueCross BlueShield of North Carolina Corporate Medical Policy for medically necessary functional endoscopic sinus surgery (FESS) to treat uncomplicated sinusitis. Have a CT scan within 6 months prior to enrollment. Be mentally and physically capable (as per physician discretion) to participate in the investigation. Be willing and able to sign the study-specific informed consent prior to any study-related procedures. Be willing and able to undergo balloon dilation in the clinic setting. Exclusion Criteria: Have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation. Have presence of features consistent with sinus fungal disease. Have evidence of gross polypoid disease within any of the sinuses or within the infundibulum. Require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc). Have previous sinus surgery (eg, sinus surgery or balloon sinuplasty). Have nasal surgery (eg, septoplasty, turbinate reduction) performed within 3 months prior to enrollment. Have any anatomical anomaly (ie, severe septal deviation) preventing transnasal access to the maxillary sinus outflow tract. Have a history of primary ciliary dysfunction. Have hemophilia. Be currently undergoing, or have undergone in the past 6 months, chemotherapy for cancer or radiation therapy in the head or neck region. Have a history of cystic fibrosis. Have Sampter's Triad (ie, defined as having all 3 of the following: aspirin sensitivity, asthma, and sinonasal polyposis). Have known sinonasal tumors or obstructive lesions. Be pregnant at the time of enrollment. Be unable to stop anticoagulant medication (eg, warfarin) until the International Normalized Ratio (INR) is below 1.5. Be unable to stop antiplatelet (eg, clopidogrel, aspirin, etc.) for at least 7 days prior to study procedure. Be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

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 |
| --- | --- |
| Experimental: Balloon sinus dilation<br>Balloon dilation of the maxillary sinus using a transnasal approach. | Device: Balloon sinus dilation<br> <br> * Other names: XprESS Multi-Sinus Balloon Dilation Tool;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNOT-20 Score | The 20-item Sino-Nasal Outcomes Test (SNOT-20) is a validated patient-reported outcome measure for assessing the presence and severity of symptoms of chronic rhinosinusitis. Symptoms on the SNOT-20 survey are each rated on a scale from 0 (no problem) to 5 (problem as bad as it can be) and the 20 symptom scores are averaged to provide a total score ranging from 0 to 5. The minimal clinically important difference in the SNOT-20 has been determined to be a reduction greater or equal to 0.8 in the total SNOT-20 score. | Baseline and 6 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery Time | Patient-reported time from procedure to ability to return to normal daily activities. | 1 week post procedure | 
| Procedural Pain Scores | Procedure pain/discomfort on a scale of 0 (no pain) to 10 (severe pain) as reported by the participant. | Immediately post procedure | 
| Revision Rate | The number of participants who require revision sinus surgery during the study duration. | 6 Months post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Balloon sinus dilation, Balloon catheters, Sinuplasty