Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up

Study Overview
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Brief Summary
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The objective of this study is to show that long-term symptom improvement after sinus balloon dilation is not worse than symptom improvement after functional endoscopic sinus surgery (FESS) and that fewer postoperative debridements are required after balloon dilation than after FESS.

Detailed Description
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This is a postmarket, multicenter, prospective, randomized clinical trial conducted at up to 15 US clinical sites comparing the efficacy of balloon sinus dilation with traditional endoscopic sinus surgery. The primary hypotheses were to demonstrate that: 1) long-term change in sinus symptoms after balloon dilation is not worse (non-inferior) than after FESS, and 2) balloon dilation is superior to FESS for a reduction in the number of postoperative debridements per patient. A minimum of 36 participants per arm is required to test the primary hypotheses. All participants will be followed through a minimum of 12 months post treatment.

Official Title
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Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Device: Balloon Sinus Dilation
* Procedure: Functional Endoscopic Sinus Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older maxillary sinus disease chronic sinusitis Exclusion Criteria: fungal disease Samter's triad hemophilia prior sinus surgery

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Balloon Sinus Dilation<br>XprESS Multi-Sinus Dilation Balloon, FinESS Sinus Treatment | Device: Balloon Sinus Dilation<br>* Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment<br>|
| Active Comparator: Functional Endoscopic Sinus Surgery<br>Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools. | Procedure: Functional Endoscopic Sinus Surgery<br>* Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sinus Symptom Improvement | Change from baseline in overall 20-item Sino-Nasal Outcome Test (SNOT-20) score. The SNOT-20 is a validated patient reported survey of 20 items related to sinonasal symptoms and severity assessed over the previous 2 weeks. Each item is scored from 0 (no problem) to 5 (problem as bad as it can be). The individual item scores are averaged to provide and overall score that ranges from 0 (best) to 5 (worst). | Baseline and 1-year | 
| Debridements | Number of postoperative debridements per participant | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Revision Rate | Number of participants requiring repeat sinus procedures | 1-year | 
| Complication Rate | Number of participants experiencing 1 or more serious adverse events related to the device and/or procedure | Duration of study (minimum of 12 months) | 
| Recovery Time | Mean time (days) after procedure for participants to return to normal activities | 6-months |