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A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body.
Sponsor: Nasotrak Medical Pte Ltd
Summary
The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.
Official title: A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-11-01
Completion Date
2025-06-30
Last Updated
2024-10-15
Healthy Volunteers
No
Conditions
Interventions
Nasotrak System
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.
Locations (2)
Parkview Regional Medical Center
Fort Wayne, Indiana, United States
Columbia University Medical Center
New York, New York, United States