Entarik Feeding Tube System for Nasogastric Tube

No longer recruiting at 1 trial location

Overseen By Carleen Tabari

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gravitas Medical, Inc.

Must not be taking: Anticoagulation therapy

Disqualifiers: Esophagitis, GI bleeding, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new feeding tube system called the Entarik Feeding Tube System in adults in the ICU. The study compares two groups: one using the Entarik system with guidance and another using it without guidance. It targets ICU patients who require a nasogastric (NG) feeding tube for nutrition. Suitable candidates are those who have been in the ICU and need a feeding tube for more than six hours. Individuals with conditions such as a history of nosebleeds or GI bleeding disorders are not eligible. As an unphased trial, this study allows patients to contribute to the development of innovative medical solutions.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that the Entarik Feeding Tube System is safe for use in ICU patients?

Research has shown that nasogastric (NG) tubes can sometimes cause serious issues, such as incorrect placement or complications. These problems, reported for many years, can lead to harm, including breathing difficulties or even death. One study found that more than half of the misplaced feeding tubes resulted in complications. These issues are termed "Never Events" because they are considered preventable.

The Entarik Feeding Tube System aims to improve tube placement to reduce such risks. However, specific data on the safety of this new system is not yet available. As the study is in the "Not Applicable" phase, it may not have collected extensive safety data. This phase involves testing how well patients can handle the system. Participation in this trial will help gather more information about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Entarik Feeding Tube System because it introduces a guided placement technique for nasogastric tubes, which could enhance accuracy and safety compared to traditional blind placements. Unlike standard feeding tube placements that rely on tactile feedback and practitioner experience, the Entarik system uses advanced guidance technology to ensure the tube is correctly positioned. This could reduce complications, like misplacement into the lungs, and improve patient outcomes. By offering a more reliable method, the Entarik system has the potential to set a new standard in enteral feeding practices.

What evidence suggests that the Entarik Feeding Tube System is effective for nasogastric tube placement?

Previous studies have shown that the Entarik Feeding Tube System makes feeding tube placement safer and more effective. Research indicates that this system can accurately locate the correct spot in the stomach, reducing the risk of incorrect placement, which can cause serious problems. Additionally, the system provides real-time alerts if the tube moves, helping to prevent issues before they become serious. The FDA has cleared the Entarik system, confirming it meets safety and effectiveness standards for patient use. Participants in this trial will receive either the Entarik Feeding Tube System with guided placement or the control method without monitor guidance to compare the effectiveness of these approaches. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Adults in the ICU who can swallow tablets, need a nasogastric tube for nutrition and medications, and are expected to use it for more than 6 hours. They must be able to consent or have someone who can consent for them. Excluded are those with major GI issues, imminent death risk, MRI needs soon, pregnancy, or deemed unsuitable by the investigator.

Inclusion Criteria

Able to provide informed consent or have a legally authorized representative provide informed consent

I need a specific size feeding tube in the ICU.

I expect to be fed through a tube for more than 6 hours in the ICU.

Exclusion Criteria

Currently pregnant

I have a history of delayed stomach emptying.

I have a significant gastrointestinal condition or surgery history.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Entarik Feeding Tube System placement in the ICU for administration of nutrition, fluids, and medications

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Entarik Feeding Tube System Placement

Trial Overview The trial is testing the Entarik Feeding Tube System's safety and effectiveness in delivering nutrition and medication in adult ICU patients. One group will use the system with monitoring while another without monitoring to compare outcomes.

How Is the Trial Designed?

Group I: Entarik Experimental Treatment 1 Intervention

Entarik FT System guided placement

Group II: Control Active Control 1 Intervention

Entarik Ft placement placement not guided with monitor

Who Is Running the Clinical Trial?

Gravitas Medical, Inc.

Lead Sponsor

Trials

4

Recruited

280+

Citations

1. withpower.com withpower.com/trial/phase-nasogastric-tube-4-2023-f02cc

Entarik Feeding Tube System for Nasogastric Tube 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 ...

2. sciencedirect.com sciencedirect.com/science/article/am/pii/S0899900723001739

Evaluation of a novel platform for placement confirmation of ... Objective: To validate the ability of a novel, impedance-based platform for nasogastric feeding tube (FT) insertion to correctly predict intragastric FT ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0899900723001739

Evaluation of a novel platform for placement confirmation ... The aim of this study was to validate the ability of a novel, impedance-based platform for nasogastric feeding tube (FT) insertion to correctly predict ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10439641/

Nasogastric tube insertion length measurement and tip ... After blind placement, verifying correct gastric tip positioning is of major importance to avoid serious and sometimes lethal complications.

5. medtechinnovator.org medtechinnovator.org/gravitas-medical-announces-us-fda-clearance-of-the-entarik-platform/

Gravitas Medical Announces US FDA Clearance of the ... The system assists in reducing the incidence of misplacement during first positioning and provides real-time alerts of tube migration. “There is ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12175294/

Patient safety matters: reducing the risks of nasogastric tubes For the last 30 years, there have been reports in the medical literature of deaths and other harm resulting from misplaced nasogastric tubes, most commonly ...

7. hssib.org.uk hssib.org.uk/patient-safety-investigations/placement-of-nasogastric-tubes/investigation-report/

Investigation report: Placement of nasogastric tubes This investigation examined patient safety issues related to the placement of nasogastric (NG) tubes.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7798396/

Nasogastric/nasoenteric tube-related adverse events Nasogastric/nasoenteric tube related adverse events are relatively common and the majority involved respiratory harm that resulted in increased hospitalization ...

9. patientsafety.pa.gov patientsafety.pa.gov/ADVISORIES/Pages/201712_feedingtubes.aspx

Complications Linked to Iatrogenic Enteral Feeding Tube ... Analysis of enteral feeding tube misplacements over a six-year period found more than half led to complications, including death.

10. bapen.org.uk bapen.org.uk/pdfs/ngsig/a-position-paper-on-nasogastric-tube-safety-v2.pdf

A Position Paper on Nasogastric Tube Safety Misplacement and use of nasogastric feeding tubes leads to ongoing avoidable complications and deaths classified as Never Events despite multiple NHS Alerts ...