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| Name | Class |
|---|---|
| Theranova, L.L.C. | INDUSTRY |
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In this single-site study, data will be recorded during nasogastric or orogastric placement (and post-pyloric placement) and removal of the Entarik Feeding Tube. Data will also be collected prior to, during, and following the delivery of a meal through the feeding tube.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Adults | Experimental | An Entarik feeding tube will be introduced and subjects will receive a meal administered through the feeding tube. Ultrasound and other data will be recorded before, during and after the meal is administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feeding tube (Entarik) | Device | Feeding tube placement will be verified using multiple methods in the duodenum and stomach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from device-related adverse events | The incidence and severity of Adverse Events (AEs) including device and procedure-related AEs and the incidence and severity of Serious Adverse Events (SAEs) will be evaluated throughout the study. Based on the non-invasive nature of the device and clinical experience gained to date, there are expected to be no SAEs nor Unanticipated Adverse Device Effects (UADEs) in the study. If any SAEs or UADEs occur they will be documented and reported, but there are no planned formal hypotheses associated with the evaluation of safety. | From enrollment to end of study (1 day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical | Contact | 415-926-8616 | clinicalstudy@theranova.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Sorrentino, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gravitas Medical, Inc. | Recruiting | Berkeley | California | 94710 | United States |
This is a device development study. Subject data may be shared at a later time at the sponsor's discretion.
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| ID | Term |
|---|---|
| D004750 | Enteral Nutrition |
| ID | Term |
|---|---|
| D005248 | Feeding Methods |
| D013812 | Therapeutics |
| D018529 | Nutritional Support |
| D044623 | Nutrition Therapy |
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