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The goal of this study is to evaluate basic usability and confirm expected safety and effectiveness of SinuSys Dilation System when used to dilate frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis.
A multicenter, single arm, prospective study conducted to assess the safety and effectiveness of an osmotically-drive, low-pressure expansion device for dilation of frontal recess and sphenoid sinus ostia in patients with chronic rhinosinusitis (CRS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SinuSys Dilation System | Experimental | Opening of previously constrained frontal recess and/or sphenoid sinus ostia via dilation procedure (sinuplasty) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sinusys Dilation System | Device | Dilation of frontal recess and/or sphenoid sinus ostia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patency of treated target site | Patency assessed by investigator via endoscopic evaluation of the target site | Patency immediately post device expansion and removal |
| Measure | Description | Time Frame |
|---|---|---|
| Patency of treated target site | Patency assessed by investigator via endoscopic evaluation of the target site | 1 month and 3 months |
| Reports of sinus related adverse events during the 3 months follow-up period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerome Hester, MD | SinuSys Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Upland ENT | Upland | California | 91786 | United States | ||
| Colorado ENT |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| up to 3 months |
| Denver |
| Colorado |
| 80210 |
| United States |
| St. Elizabeth Medical Center | Brighton | Massachusetts | 02135 | United States |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |