Nasogastric TubeNCT05884216
Entarik Feeding Tube System Placement in Adult ICU
A study testing Entarik Feeding Tube System and Entarik Feeding Tube System without monitoring in people with Nasogastric Tube, run by Gravitas Medical, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasogastric Tube
- What is being tested?
- Entarik Feeding Tube System and Entarik Feeding Tube System without monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 May 2023to 23 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nova Clinical Research at HCA Florida Blake Hospital
Bradenton, Florida, 34209
HCA Chippenham and Johnston-Willis Medical Center
Richmond, Virginia, 23225
About this study
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.
- Conditions
- Nasogastric Tube
- Being tested
- Entarik Feeding Tube System, Entarik Feeding Tube System without monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entarik Feeding Tube SystemDevice
Entarik Feeding Tube:
The Entarik Feeding Tube 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.
Entarik Feeding Tube System:
The Entarik Feeding Tube System is designed to aid qualified operators in the placement of the Entarik Feeding Tube (Entarik FT) into the stomach of patients requiring enteral feeding. The Entarik FT is equipped with sensors designed to provide information about the location of the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik Monitor also monitors the feeding tube position continuously during the course of feeding and automatically and in real-time alerts of tube migration.
Entarik Feeding Tube System without monitoringDevice
Entarik Feeding Tube:
The Entarik Feeding Tube 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.
Entarik Feeding Tube System:
The Entarik Feeding Tube System will collect data from the Entarik Feeding Tube. There will be no monitoring or dislodgement alerts, and no placement guidance.
| Study group | Role | What they receive |
|---|---|---|
| Entarik | Experimental | Entarik FT System guided placement Receives: Device: Entarik Feeding Tube System |
| Control | Active comparator | Entarik Ft placement placement not guided with monitor Receives: Device: Entarik Feeding Tube System without monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
All patients will receive placement verification per institutional standard of care.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start30 May 2023
- Primary completion15 Jan 2025
- Study completion23 Jan 2025
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasogastric TubeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gravitas Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884216
- Sponsor's protocol ID
- CRD-04-1642-01
- Status last verified
- Nov 2025
- First submitted
- 18 Apr 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Entarik Feeding Tube System Placement in Adult ICU
- ClinicalTrials.gov ID
- NCT05884216
- Acronym / sponsor ID
- CRD-04-1642-01
- Conditions
- Nasogastric Tube
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Gravitas Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 May 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Entarik | Experimental | Device: Entarik Feeding Tube SystemEntarik FT System guided placement |
| Control | Active comparator | Device: Entarik Feeding Tube System without monitoringEntarik Ft placement placement not guided with monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entarik Feeding Tube SystemEntarik Feeding Tube: The Entarik Feeding Tube 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. Entarik Feeding Tube System: The Entarik Feeding Tube System is designed to aid qualified operators in the placement of the Entarik Feeding Tube (Entarik FT) into the stomach of patients requiring enteral feeding. The Entarik FT is equipped with sensors designed to provide information about the location of the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik Monitor also monitors the feeding tube position continuously during the course of feeding and automatically and in real-time alerts of tube migration. | Device | Entarik |
| Entarik Feeding Tube System without monitoringEntarik Feeding Tube: The Entarik Feeding Tube 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. Entarik Feeding Tube System: The Entarik Feeding Tube System will collect data from the Entarik Feeding Tube. There will be no monitoring or dislodgement alerts, and no placement guidance. | Device | Control |
Primary outcome
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.
Time frame: 1 year
All patients will receive placement verification per institutional standard of care.
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Entarik Feeding Tube System and Entarik Feeding Tube System without monitoring in people with Nasogastric Tube, run by Gravitas Medical, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.