CClinicalTrials.gg
Sign In
Not yet recruitingNCT06497088Updated Oct 15, 2024

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

An interventional study of Nasotrak System in Nasogastric Tube Placement, sponsored by Nasotrak Medical Pte Ltd. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.

Sponsored by Nasotrak Medical Pte Ltd · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Nasogastric Tube Placement
03

In context

Lead sponsor

This is the only study on the registry with Nasotrak Medical Pte Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Nasotrak System

    Device: Nasotrak System

Interventions

  • DeviceNasotrak 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.

06

What researchers measure

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

07

Study locations

2 sites
  • Parkview Regional Medical Center
    Fort Wayne, Indiana 46845, United States
  • Columbia University Medical Center
    New York, New York 10032, United States
    • Amanda Alonso · Contact · aa2974@cumc.columbia.edu · 212-342-0261
    • Michael Owen-Michaane, MD, MA, CNSC · Contact
    • David S. Seres, MD, ScM, PNS, FASPEN · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06497088
Lead sponsor
Nasotrak Medical Pte Ltd
Responsible party
Sponsor
First posted
Jul 11, 2024
Start date
Nov 1, 2024 (estimated)
Primary completion
Jun 30, 2025 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Oct 15, 2024

Study contacts

David Tan
Contact
david@nasotrak.com.sg
+65 6461 7016
David Tan, Beng
study chair · Nasotrak Medical Pte Ltd

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion