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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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A non-randomized, multi-center, prospective, clinical study intended to evaluate the safety and efficacy of balloon sinuplasty devices in pediatric patients with longstanding sinusitis following failed medical management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Relieva™ Balloon Sinuplasty™ System | Other | Balloon Dilation of sinus ostium |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Relieva™ Balloon Sinuplasty™ System | Device | Balloon dilation will be performed using endoscopic equipment with video documentation capability. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months | Number of device-related adverse events from time of procedure through 12 months post-procedure. | 12 months |
| Effectiveness: Change in Sinus Symptom Scores (SN-5) | Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement. | 12 months |
| Effectiveness: Change in Sinus Symptom Scores (SNOT-20) | Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success: Ability to Access/Dilate Sinus Ostia | Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted. | 12 months |
| Effectiveness: Medication Thru 1 yr |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hassan Ramadan, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Balloon Device | Balloon catheter dilation of sinus ostia |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Device | Balloon catheter dilation of sinus ostia |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months | Number of device-related adverse events from time of procedure through 12 months post-procedure. | Posted | Number | number of events | 12 months |
|
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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 | Balloon Device | Balloon catheter dilation of sinus ostia |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura England, Manager-Clinical | Acclarent, Inc. | 650-687-4466 | lenglan1@its.jnj.com |
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Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation.
| 12 months |
| Effectiveness of Dilation/Measured by Post-op Interventions | Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported. | 12 months |
| Days Out of School During the 12 Months of Follow-up | Quantitative assessment of days out of school during the 12 months of follow-up. | 12 months |
| Revision Rate | The number of subjects requiring revisions out of 33 subjects treated. | at 1 year |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Primary | Effectiveness: Change in Sinus Symptom Scores (SN-5) | Change in sinus symptoms (mean reduction) for subjects less than 12 years of age evaluated using the SN-5 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SN-5 is seven and the minimum is one. A reduction in SN-5 score indicates improvement. | Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores). | Posted | Mean | Standard Deviation | change in SN-5 score | 12 months |
|
|
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| Secondary | Device Success: Ability to Access/Dilate Sinus Ostia | Percentage of sinuses treated which were considered procedure success by the investigator relative to sinuses attempted. | intent to treat analysis | Posted | Number | percentage of sinuses successful | 12 months | sinuses | sinuses |
|
|
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| Secondary | Effectiveness: Medication Thru 1 yr | Data was summarized from the Global Patient Assessment Form. Each subject's last observation was used in order to account for any missing data or early termination of subjects. The results indicated represents the proportion of subjects (expressed as a percentage) who reported a decrease in medication usage at the time of their study discontinuation. | Posted | Number | percentage of participants | 12 months |
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|
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| Secondary | Effectiveness of Dilation/Measured by Post-op Interventions | Effectiveness of balloon dilation as measured by the need for post-operative interventions other than revision sinus surgery. This endpoint evaluation includes irrigation and debridement. Number of post-operative interventions reported. | Posted | Number | number of interventions | 12 months |
|
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| Secondary | Days Out of School During the 12 Months of Follow-up | Quantitative assessment of days out of school during the 12 months of follow-up. | Posted | Mean | Standard Deviation | days | 12 months |
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| Secondary | Revision Rate | The number of subjects requiring revisions out of 33 subjects treated. | Posted | Number | participants | at 1 year |
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| Primary | Effectiveness: Change in Sinus Symptom Scores (SNOT-20) | Change in sinus symptoms (mean reduction) for subjects 12 years of age or greater evaluated using the SNOT-20 questionnaire at 52 weeks post-procedure compared to baseline. The maximum possible score for the SNOT-20 is five and the minimum is zero. A reduction is SNOT-20 score indicates improvement. | Data calculated for matched pairs (subjects with baseline and 12 months follow-up scores). | Posted | Mean | Standard Deviation | change in SNOT-20 score | 12 months |
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