Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis

Study Overview
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Brief Summary
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A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.

Official Title
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Clinical Evaluation of Confirm the Safety and Efficacy of Balloon Sinuplasty Devices in the Treatment of Pediatric Sinusitis

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Device: Relieva™ Balloon Sinuplasty™ System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 2 and < 18 years Both male and female patients eligible Planned surgical intervention (i.e. endoscopic sinus surgery, adenoidectomy, sinus irrigation for obtaining a culture) recommended by PI, consented to by patient's legal guardian) Longstanding sinusitis: >3 mo symptoms OR 6 episodes/yr AND failed 2 courses antibiotics followed by positive CT scan Exclusion Criteria: Extensive previous sinonasal surgery in target ostia Cystic fibrosis Extensive sinonasal osteoneogenesis Sinonasal tumors or obstructive lesions History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium Ciliary dysfunction For female patients of childbearing age: the patient is either pregnant or lactating

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 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: Relieva™ Balloon Sinuplasty™ System<br>Balloon Dilation of sinus ostium | Device: Relieva™ Balloon Sinuplasty™ System<br>* Balloon dilation will be performed using endoscopic equipment with video documentation capability.<br>* Other names: Relieva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months | Number of device-related adverse events from time of procedure through 12 months post-procedure. | 12 months | 
| Effectiveness: Change in Sinus Symptom Scores (SN-5) | Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement. | 12 months | 
| Effectiveness: Change in Sinus Symptom Scores (SNOT-20) | Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success: Ability to Access/Dilate Sinus Ostia | Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted. | 12 months | 
| Effectiveness: Medication Thru 1 yr | Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation. | 12 months | 
| Effectiveness of Dilation/Measured by Post-op Interventions | Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported. | 12 months | 
| Days Out of School During the 12 Months of Follow-up | Quantitative assessment of days out of school during the 12 months of follow-up. | 12 months | 
| Revision Rate | The number of subjects requiring revisions out of 33 subjects treated. | at 1 year |