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The purpose of this study is to assess safety and performance of the SinuSys Dilation System for dilation of the maxillary sinus ostium.
A multicenter, single-arm, prospective study conducted to assess the safety and effectiveness of a new osmotically-driven, low-pressure expansion device for dilation of maxillary sinus ostia in patients with (CRS) Chronic Rhinosinusitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SinuSys Dilation System | Experimental | Maxillary Sinus Dilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SinuSys Dilation System | Device | Sinuplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patency of Treated Area | Immediately post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patency of Treated Area | Maxillary Sinus Ostia Patency of 33 patients analyzed. | 3 months |
| Number of Participants With Device-related Adverse Events as a Measure of Safety | 3 months |
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Inclusion Criteria:
-Diagnosis of chronic maxillary sinusitis
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Catalano, MD | St Elizabeth Medical Center | Principal Investigator |
| Amin Javer, MD | St. Paul's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valley ENT | Tucson | Arizona | 85745 | United States | ||
| Palo Alto Medical Foundation |
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| ID | Title | Description |
|---|---|---|
| FG000 | SinuSys Dilation System | Maxillary Sinus Dilation |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
36 patients were enrolled; 2 patients withdrew consent prior to treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | SinuSys Dilation System | Maxillary Sinus Dilation SinuSys Dilation System: Sinuplasty |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patency of Treated Area | Number of osita treated | Posted | Number | percentage of ostia treated | Immediately post procedure | Ostia | Participants |
|
|
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Only device related adverse events collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SinuSys Dilation System | Maxillary Sinus Dilation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Janie Mandrusov, Director of Pre-Clinical and Clinical Development | SinuSys Corporation | 4084104411 | emandrusov@sinusys.com |
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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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| Patency of Treated Area | Maxillary Sinus Ostia Patency of 29 patients analyzed. | 6 months |
| Patency of Treated Area | Maxillary Sinus Ostia of 27 patients analyzed. | 12 months |
| Palo Alto |
| California |
| 94301 |
| United States |
| St. Elizabeth Medical Center | Boston | Massachusetts | 02135 | United States |
| St. Paul's Hospital, ENT Department | Vancouver | British Columbia | BC V6Z 1Y6 | Canada |
| Charing Cross Hospital | London | United Kingdom |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Ostia |
|
|
| Secondary | Patency of Treated Area | Maxillary Sinus Ostia Patency of 33 patients analyzed. | One patient was lost to follow up | Posted | Number | percentage of ostia patent | 3 months | Ostia | Participants |
|
|
|
| Secondary | Number of Participants With Device-related Adverse Events as a Measure of Safety | Posted | Number | number of participants | 3 months |
|
|
|
| Secondary | Patency of Treated Area | Maxillary Sinus Ostia Patency of 29 patients analyzed. | 5 patients were lost to follow up | Posted | Number | percentage of ostia patent | 6 months | Ostia | Participants |
|
|
|
| Secondary | Patency of Treated Area | Maxillary Sinus Ostia of 27 patients analyzed. | 7 patients were lost to follow up | Posted | Number | percentage of ostia patent | 12 months | Ostia | Participants |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
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| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |