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

NCT06497088 | Not Yet Recruiting FDA Device

• 1 other identifier: NST-DHF-076
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Nasogastric Tube Placement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Nasotrak System

EXPERIMENTAL

Device: Nasotrak System

Interventions

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.

Nasotrak System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nasotrak Medical Pte Ltd: lead

Study Sites (2)

Parkview Regional Medical Center

Fort Wayne, Indiana, 46845, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Study Officials

• David Tan, Beng

  Nasotrak Medical Pte Ltd

  STUDY CHAIR

Central Study Contacts

David Tan

CONTACT

+65 6461 7016; david@nasotrak.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 11, 2024
• Study Start: November 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

US (2)