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The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasotrak System | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasotrak System | Device | Device: The Nasotrak System The Nasotrak Medical System is intended to aid, in conjunction with institutional protocols, qualified operators in the placement of the Nasotrak's 12 Fr feeding tube into the stomach of patients requiring enteral feeding after insertion and before every feed. The Nasotrak nasogastric tube(NGT) is designed for use with Nasotrak's handheld device (HHD) which is able to detect the tip of the NGT via piezoelectric sensor, which converts ultrasound waves to electronic signals, thus assisting to track its location as an indicator of placement in the stomach. Nasotrak's NGT is intended only to be used with Nasotrak's HHD. The Nasotrak NGT is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the effectiveness of detecting Nasotrak's nasogastric tube's distal tip using Nasotrak's ultrasound verification algorithm compared to X-ray. | All patients will receive placement verification per institutional practice | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Tan | Contact | +65 6461 7016 | david@nasotrak.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| David Tan, Beng | Nasotrak Medical Pte Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkview Regional Medical Center | Fort Wayne | Indiana | 46845 | United States |
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| Columbia University Medical Center | New York | New York | 10032 | United States |
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