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| ID | Type | Description | Link |
|---|---|---|---|
| R44AG076248 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to evaluate the airway detection performance of the Entarik Feeding Tube System, and to collect data when the Entarik Feeding Tube is in the Airway for device development.
The study is a prospective, single center, non-blinded, single arm study. Subjects who are scheduled to undergo an elective bronchoscopy procedure will have an Entarik Feeding Tube placed into the airway through an endotracheal tube under direct visualization while temperature and impedance data are collected by the Entarik monitor. Other data will be passively simultaneously collected through the Feeding Tube.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Adults | Experimental | Airway insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Airway insertion | Device | Tube will be inserted into the trachea to make airway data measurements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of accurate airway verifications by the Entarik feeding tube system | Percentage of accurate verifications of airway placement of the tip of the Entarik feeding tube at the Safety Check Depth. | During the airway placement procedure |
| Incidence of Adverse Events | Incidence of adverse events: (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the subject. | During the airway placement procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aaron Miller | Contact | 415-926-8616 | clinicalstudy@theranova.com |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Burnett, MD | Theranova, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital | Recruiting | Philadelphia | Pennsylvania | 19140 | United States |
Demographics and Primary Endpoint results.
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