TerminatedNot Applicable

Entarik Feeding Tube System Placement in Adult ICU

Stopped: Based on regulatory precedent for other smart feeding tubes, sufficient performance data was obtained to submit a 510(k) application with the FDA for the Entarik System.

United States45 participantsStarted 2023-05-30

Plain-language summary

The purpose of this study is to evaluate the safety and effectiveness of the Entarik Feeding Tube System in an adult ICU patient population for the administration of nutrition, fluids and medications.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, faci…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of accurate verifications of anatomical locations of the tip of the Entarik feeding tube. The position of the feeding tube tip as processed by the Entarik placement algorithm will be compared to x-ray.

Timeframe: 1 year

Trial details

NCT IDNCT05884216

SponsorGravitas Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-15

View on ClinicalTrials.gov More Nasogastric Tube trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.