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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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The economic, patient related outcome, and effectiveness of balloon sinuplasty in the treatment of CRS patients with frontal and other sinus disease in the Canadian healthcare environment is not known at this time. This study will evaluate the impact of balloon sinuplasty and traditional FESS treatment on CRS patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon Sinuplastyâ„¢ System | Active Comparator |
| |
| Functional Endoscopic Sinus Surgery | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relieva Balloon Sinuplastyâ„¢ System | Device | Catheter-based devices used to dilate blocked paranasal sinus ostia (openings). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health outcome of patients in the two treatment groups. | Health outcomes will be determined by the completion of the EQ-5D questionnaire in both treatment groups at various timepoint. The EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Witterick, MD, MSc | Mount Sinai Hospital, Toronto, Ontario, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada | ||
| St. Joseph's Health Centre |
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| Functional Endoscopic Sinus Surgery | Procedure | Specialized probes are used to cannulate closed ostia (openings), and small forceps are used to resect periostial bone and tissue to enlarge the sinus ostia. |
|
| 6 months |
| Effectiveness of the two treatment groups in relieving symptomology of CRS. | Effectiveness of the two treatment groups in relieving symptomology of CRS will be determined by the completion of the Sino-nasal Outcome Test - 20 (SNOT-20) questionnaire in both treatment groups at various timepoint. The SNOT-20 questionnaire is a validated instrument for the measurement of disease specific health status and quality of life in patients with chronic rhinosinusitis. | 6 months |
| London |
| Ontario |
| N6A 4V2 |
| Canada |
| Ottawa Hospital - Civic Campus | Ottawa | Ontario | K1Y 4E9 | Canada |
| Trillium Health Centre | Toronto | Ontario | L5C 4E9 | Canada |
| Toronto East General | Toronto | Ontario | M4C 3E7 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| St. Joseph's Health Centre | Toronto | Ontario | M6R 1B5 | Canada |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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