A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body.

A Clinical Study to Evaluate the Ultrasonic Detection of a Novel Nasogastric Tube in the Human Body

The purpose of this study is to evaluate the safety, efficacy and accuracy of the Nasotrak System in an adult patient population.

Study Overview

• Status: Not yet recruiting
• Conditions: Nasogastric Tube Placement
• Intervention / Treatment: Device: Nasotrak System

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Tan; Phone Number: +65 6461 7016; Email: david@nasotrak.com.sg

Study Locations

• United States
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Regional Medical Center
      • Contact: Jan Powers, PhD; Phone Number: (260) 266-7761; Email: jan.powers@parkview.com
      • Contact: Jan Powers, PhD
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
      • Contact: Amanda Alonso; Phone Number: 212-342-0261; Email: aa2974@cumc.columbia.edu
      • Contact: Michael Owen-Michaane, MD, MA, CNSC
      • Contact: David S. Seres, MD, ScM, PNS, FASPEN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults greater than 18 years of age
• Able to provide informed consent or have a legally authorized representative available to provide informed consent in English
• Clinically requiring a 12 Fr NG/OG tube with X-ray confirmation per standard protocol

Exclusion Criteria:

• Female subjects of childbearing age with known pregnancy or lactating.
• Prisoners.
• Unable to consent in English.
• Subjects/ volunteers with pacemakers or life-sustaining devices in the body such as ICD.
• Subjects with a history of:
• Esophageal varices or ulcers.
• Upper airway obstruction.
• Upper GI stenosis or obstruction.
• Trauma involving sinuses, nares face or neck that would prevent nasogastric (NG) or oral tube insertion.
• Deformities of the sinus cavities and/or skull base.
• Esophageal cancer or neoplasm.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Nasotrak System

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Nasotrak Medical Pte Ltd
• Investigators: Study Chair: David Tan, Beng, Nasotrak Medical Pte Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 4, 2024
• First Posted (Actual): July 11, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: NST-DHF-076

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No