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This is a prospective, non-randomized, single-arm study designed to assess the safety and device performance of the NuVent navigation-guided balloon system for use in subjects with scarred, granulated, or previously surgically altered tissue (revision).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NuVent™ | Experimental | Revision patients treated with NuVent™ |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electromagnetic Sinus Dilation System (NuVent™) | Device | NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia. |
| Measure | Description | Time Frame |
|---|---|---|
| Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium | Two-fold endpoint: Investigator-assessment regarding the number of sinuses that were easily navigated to the desired treatment location and easy dilation of the ostium | At time of surgery |
| Device-related Adverse Event Point Estimate | The primary safety endpoint was the point estimate (and confidence interval) for all AEs that were directly attributable to the device or for which the cause could not be determined and that met the definition of designated primary safety endpoint AEs as defined in the protocol. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Device Safety Profile as Measured by the Overall Adverse Event Rate | Overall adverse event rate | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philadelphia | Pennsylvania | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NuVent™ | Revision patients treated with NuVent™ Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Revision patients treated with NuVent
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| ID | Title | Description |
|---|---|---|
| BG000 | NuVent™ | Revision patients treated with NuVent™ Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the 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, 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 | Navigation to the Desired Sinus Treatment Location and Dilation of the Ostium | Two-fold endpoint: Investigator-assessment regarding the number of sinuses that were easily navigated to the desired treatment location and easy dilation of the ostium | All patients that completed the study | Posted | Number | Number of sinuses | At time of surgery |
|
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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 | NuVent™ | Revision patients treated with NuVent™ Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Medtronic Xomed | 904-296-9600 | dl.nuventstudy@medtronic.com |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
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| Participants |
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| Primary | Device-related Adverse Event Point Estimate | The primary safety endpoint was the point estimate (and confidence interval) for all AEs that were directly attributable to the device or for which the cause could not be determined and that met the definition of designated primary safety endpoint AEs as defined in the protocol. | Participants | Posted | Number | 95% Confidence Interval | Adverse Events | 2 weeks |
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| Secondary | Device Safety Profile as Measured by the Overall Adverse Event Rate | Overall adverse event rate | Posted | Number | Percentage of participants with an AE | 2 weeks |
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| 0 |
| 51 |
| 0 |
| 51 |
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