Optimization and Refinement of Technique in In-Office Sinus Dilation 2

Study Overview
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Brief Summary
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A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.

Official Title
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Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)

Conditions
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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: Male/Female, 18 year or older Diagnosis of Chronic Rhinosinusitis Planned Endoscopic Sinus surgery Exclusion Criteria: Cystic Fibrosis Severe Polyposis Sinonasal tumors History of facial trauma precluding access to sinus ostium Ciliary Disfunction Planned non-sinus surgery (such as rhinoplasty, septoplasty, etc.) Pregnant or lactating female Inability to tolerate an awake procedure Participation in another investigational clinical study involving treatment for chronic rhinosinusitis

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Balloon catheter device<br>Dilation of sinuses using Relieva Balloon Sinuplasty System | Device: Relieva Balloon Sinuplasty System<br>* Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intra-patient Change in SNOT-20 Score | Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data. The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5. | Baseline and 24 weeks | 
| Mean Intra-patient Change in Lund-Mackay CT Scan Score | Change in Lund-Mackay CT score for paired baseline and 24 week data. The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden. | Baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Tolerability | Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable. | Day 0 (Day of Procedure) | 
| Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary | Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary | Day 0 (Day of Procedure) | 
| Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events. | Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events. | Day 0 (Day of Procedure) | 
| Mean Number of Days to Return to Normal Activities | Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living | 2 weeks |