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New feeding tube device tested in ICU – but study halted early

NCT ID NCT05884216

Knowledge-focused Sponsor: Gravitas Medical, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the Entarik Feeding Tube System, a device designed to help place feeding tubes in the stomach of ICU patients who cannot eat normally. The system uses sensors to check if the tube is in the right spot, compared to standard X-ray checks. The trial enrolled 45 adults but was terminated early, so the full safety and effectiveness are not yet known.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Entarik Feeding Tube System (device)
What this could lead to
If successful, this device could make feeding tube placement in ICU patients faster and more reliable, reducing the need for X-ray confirmation.
What could go wrong
The study was terminated early with only 45 participants, so results are limited. The device may not work as well in all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

45 people

The number who actually took part.

Started

May 2023

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Must be able to swallow tabletsAt least 18 years old * Able to provide informed consent or ability to have a legally authorized representative provide informed consent * Adults in the ICU requiring an 8Fr, 10Fr, or 12Fr NG tube. The size of the feeding tube should be determined clinically, and the Entarik Feeding Tube should only be placed if that size is appropriate. * Suitable to start enteral (gastric but no post-pyloric) feeding * Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the ICU. If enteral nutrition has already been initiated, indicated for replacement of an NG feeding tube Note: Both subjects on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study. Exclusion Criteria: * inability to receive a feeding tube including subjects with known history of issues such as esophagitis or strictures, frequent nose bleeds, basilar skull fracture or GI bleeding disorders * Known major upper airway malformation * Known major GI abnormality, upper GI malignancy, or partial gastric resection * History of gastroparesis * Currently pregnant * NPO status - expected to remain NPO for the following 72 hours. * Patient needs an MRI in the immediate future (e.g., 6-12h) where placement of the feeding tube (non-MRI compatible) is going to mandate replacement with standard feeding tube * Critically ill, facing imminent death * Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Nasogastric tube

Contacts and locations

Locations

  • HCA Chippenham and Johnston-Willis Medical Center

    Richmond, Virginia, 23225, United States

  • Nova Clinical Research at HCA Florida Blake Hospital

    Bradenton, Florida, 34209, United States

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