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NCT Number: NCT06497088

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.

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Key information

Conditions

Nasogastric Tube Placement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkview Regional Medical Center, Fort Wayne, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

    Time frame: 1 year

    All patients will receive placement verification per institutional practice

Study contacts

Contact information is provided by the study sponsor or research team.

David Tan

CONTACT

[email protected]

+65 6461 7016

Sponsors and collaborators

Lead sponsor

Nasotrak Medical Pte Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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