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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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The study will evaluate the performance and reliability of minor design changes to the Acclarent Iontophoresis System components for anesthetizing the tympanic membrane in healthy volunteers. Data collected from this study will enable the development of future applications and technology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Iontophoresis-treated | Experimental | Healthy volunteers will evaluate reliability and performance of Iontophoresis System in delivery of local anesthesia to the TM. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acclarent Iontophoresis System | Device | Administration of local anesthesia using the Acclarent Iontophoresis System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Success | Evaluation of the performance and reliability of the Acclarent Iontophoresis System in delivery of local anesthesia to the TM in healthy volunteers | X days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse effects associated with the System and the Iontophoresis procedure | The investigator will rate any adverse event that occurs during the procedure for level of severity and relationship to the study device. | X days |
| Tolerability of the iontophoresis system |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Palo Alto | California | 94303 | United States |
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Subject tolerability of the iontophoresis procedure will be assessed using a pain scale |
| X days |