A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body.
Part of paid clinical trials in Fort Wayne, Indiana.
- Sponsor
- Nasotrak Medical Pte Ltd
- Study ID
- NCT06497088
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Nasogastric Tube Placement
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Nasotrak System — DEVICEDevice: 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.
Study Details
The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.
Key Dates
- Start date
- Nov 1, 2024
- Status verified
- Oct 2024
- Primary completion
- Jun 30, 2025
- Completion
- Jun 30, 2025
Study Design
- Enrollment
- 90 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Nasotrak System
Primary Outcome Measure
Evaluate the effectiveness of detecting Nasotrak's nasogastric tube's distal tip using Nasotrak's ultrasound verification algorithm compared to X-ray. [ Time Frame: 1 year ]
Central Contacts
- David Tan+65 6461 7016
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Parkview Regional Medical Center | Fort Wayne | Indiana | 46845 | Jan Powers, PhD |
| Columbia University Medical Center | New York | New York | 10032 | Michael Owen-Michaane, MD, MA, CNSC David S. Seres, MD, ScM, PNS, FASPEN |