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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNasotrak Medical Pte Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Nasotrak SystemExperimental treatment 1 intervention

Trial outcomes

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

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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