Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

Study Overview
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Brief Summary
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The purpose of this study is to show clinically meaningful improvement in symptom severity after transnasal balloon dilation of the maxillary sinus outflow tract with or without balloon dilation of the frontal or sphenoid sinuses.

Detailed Description
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This is a prospective, non-randomized, single arm, post-approval study conducted under a common protocol designed to evaluate outcomes following trans-nasal balloon dilation of the maxillary sinus outflow tract with or without concurrent balloon dilation of the frontal or sphenoid sinuses and without any concomitant conventional sinus surgery (ie, uncinectomy, complete or partial ethmoidectomy).

Official Title
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Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study

Conditions
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Sinusitis

Intervention / Treatment
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* Device: XprESS Multi-Sinus Dilation Tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be at least age 18 years old or older. Be a candidate for transnasal balloon dilation of the maxillary sinus(es) with or without balloon dilation of the frontal or sphenoid sinus(es) using XprESS consistent with the device's Indication for Use. Have a sinus CT scan within 12 months of the procedure date. Be able and willing to provide consent. Be willing to comply with the protocol requirements. Exclusion Criteria: Have any prior maxillary sinus surgery (eg, antrostomy, uncinectomy). Require any concomitant endoscopic sinus surgery (ESS) or nasal surgery (exception: turbinate reduction) at the time of the study procedure. Have any nasal surgery (eg, septoplasty) or nonmaxillary sinus surgery (eg, frontal sinusotomy, sphenoidotomy, full/partial ethmoidectomy) performed within 3 months prior to enrollment. Have presence of features consistent with sinus fungal disease. Be allergic to nickel or barium sulfate. 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: XprESS Multi-Sinus Dilation Tool<br>Balloon sinus dilation | Device: XprESS Multi-Sinus Dilation Tool<br>* Sinus balloon dilation<br>* Other names: Sinus balloon dilation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 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 1-year post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision Sinus Surgery | The number of participants who require revision sinus surgery to address continuing sinus symptoms. | 1-year post procedure | 
| Number of Participants With Serious Device and/or Procedure-related Adverse Events | Serious adverse events that are considered to be possibly, probably, or definitely related to the balloon device and/or dilation procedure. | Through 1-year post procedure follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sinusitis, Sinus balloon dilation patients