Sinus Balloon Dilation in Pediatric Patients

Study Overview
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Brief Summary
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Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.

Official Title
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XprESS Device and PathAssist Confirmation Tools in Pediatric Patients-Expanded Indication Study

Conditions
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Sinusitis

Intervention / Treatment
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* Device: XprESS device and PathAssist confirmation tools


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age ≥ 2 to ≤ 21 years old. Diagnosed with Chronic Rhinosinusitis (CRS). Candidate for trans-nasal balloon sinus dilation. Exclusion Criteria: History of sinus surgery. Recent nasal or head and neck surgery. Fungal sinus disease. Severe asthma. Cystic fibrosis. Immunodeficiency. Craniofacial abnormalities. Pregnancy (current)

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 21 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 |
| --- | --- |
| Other: Balloon Sinus Dilation<br> | Device: XprESS device and PathAssist confirmation tools<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success: Sinuses Successfully Treated With Balloon Dilation | Number of successful dilations out of all attempted dilations. Success is defined as the device successfully delivered to the target sinus, inflated, deflated, and withdrawn from the treated sinus. | Index procedure | 
| Complications | Number of subjects who experience complications. Complications are defined as serious device or procedure related adverse events. | Index procedure through 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life From Baseline Through Completion | Change in sinonasal symptom severity between the baseline preprocedure assessment and follow-up assessment. Sinus symptom severity is measured using the Sinus and Nasal Quality of Life Survey (SN-5) that is a validated tool for use in pediatric patients (completed by caregivers). The 5 survey items are scored from 1 (best) to 7 (worst) and averaged to provide an overall score. | Baseline to 6-month follow-up | 
| Number of Subjects Who Undergo a Revision or Additional Surgery During the Study | Any surgical intervention that is performed in the sinus(es) following the index procedure will be reported | Procedure-6 month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sinus infections, sinusitis, chronic sinusitis, rhinosinusitis, allergic sinusitis, allergic rhinitis, chronic rhinosinusitis, sinus disease in children, sinus balloon dilation, balloon dilatation, sinus disease, pediatric