Gravitas Feeding Tube System for Nasogastric Tubes

Not currently recruiting at 4 trial locations

Overseen By Carleen Tabari

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Gravitas Medical, Inc.

Disqualifiers: Upper airway malformation, GI malformation, NPO status, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Gravitas Feeding Tube System to determine its effectiveness and safety for newborns in hospitals. The study focuses on infants in the NICU who require feeding tubes for nutrition, fluids, and medications. Infants in the NICU needing a nasogastric tube (a tube from the nose to the stomach) might be suitable candidates. The trial compares the new system with standard care to assess if it is better or safer. As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions for newborns.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Gravitas Feeding Tube System is safe for NICU patients?

In a previous study, researchers tested the Gravitas Feeding Tube System in newborns and found it safe. They monitored key indicators, such as temperature and electrical conductivity (to ensure correct tube placement), during the procedure. No serious problems occurred with the system during these tests.

Another report showed that the Entarik Feeding Tube System, similar to the Gravitas system, was as safe and effective as other devices used for the same purpose. This suggests that the Gravitas Feeding Tube System should also be well-tolerated.

Overall, research indicates the system is safe for use in newborns, with no major issues noted in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Gravitas Feeding Tube System is unique because it offers a potentially more efficient and comfortable delivery method for nasogastric feeding compared to traditional tubes. Researchers are excited about this system because it may reduce patient discomfort and improve the ease of insertion and stability of the tube, which are common challenges with current nasogastric tube options. By focusing on these enhancements, the Gravitas system could lead to a better overall experience for patients needing nutritional support through nasogastric tubes.

What evidence suggests that the Gravitas Feeding Tube System is effective for NICU patients?

Research has shown that the Gravitas Feeding Tube System, which participants in this trial may receive, effectively delivers nutrition, fluids, and medications to newborns. Studies have found that it safely places the tube, reducing the risk of misplacement, which can occur in up to 59% of cases with other tubes. The system uses a special method to verify correct tube placement, ensuring real-time accuracy. Overall, the Gravitas Feeding Tube System appears to be a promising option for feeding and administering medicine to newborns. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for newborns in intensive care or on a medical floor who need a nasogastric (NG) tube sized 5-8 Fr for feeding. They should be between 0 to 18 weeks old, can be up to 12 weeks premature, and must require enteral feeding for over 6 hours. Both ventilated and non-ventilated neonates are eligible if they have consent from a legal representative.

Inclusion Criteria

I am within 18 weeks after giving birth, and my baby was born at least 28 weeks into pregnancy.

I can start feeding through a tube in my stomach.

My infant needs a 5-8 Fr NG feeding tube as determined by their doctor.

Exclusion Criteria

Critically ill, facing imminent death

Known major GI malformation (e.g. malrotation)

Neonate on ECMO

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Validation of the Gravitas Feeding Tube System Placement Algorithm and evaluation of the safety and effectiveness of the Gravitas Feeding Tube in neonates

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gravitas Feeding Tube System

Trial Overview

The study tests the Gravitas Feeding Tube System's placement algorithm in neonates needing NG tubes. It assesses how well the system helps place tubes with or without monitor guidance, aiming to improve safety and effectiveness in delivering nutrition and medication.

How Is the Trial Designed?

Group I: Gravitas FT System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Gravitas Medical, Inc.

Lead Sponsor

Trials

4

Recruited

280+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12489026/

A novel neonatal feeding tube with real time placement ...

However, up to 59% of feeding tubes are misplaced in neonates, with 6% of these ending up in the upper esophagus, potentially leading to health ...

2.

app.trialscreen.org

app.trialscreen.org/trials/nasogastric-tube-gravitas-feeding-system-placement-neonates-study-nct05517707

Gravitas Feeding Tube System Placement in Neonates

The Gravitas Feeding Tube System offers safe and effective administration of nutrition, fluids, and medications in neonates.

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.

ctv.veeva.com

ctv.veeva.com/study/gravitas-feeding-tube-system-placement-validation-in-neonates

Gravitas Feeding Tube System Placement Validation in ...

The purpose of this study is to validate the Gravitas Feeding Tube System Placement Algorithm for NICU patients and to evaluate the safety and effectiveness.

5.

clinconnect.io

clinconnect.io/trials/NCT05914064

Gravitas Feeding Tube System Placement Validation in

The purpose of this study is to validate the Gravitas Feeding Tube System Placement Algorithm for NICU patients and to evaluate the safety and effectiveness ...

6.

gravitasmedinc.com

gravitasmedinc.com/wp-content/uploads/IFU-04-1404-Rev-A-Entarik-Enteral-Feeding-System.pdf

Entarik™ Feeding Tube System

This nasogastric feeding tube should not be used with connectors from other healthcare applications. Cautions. Entarik Feeding Tube System. ○ Use only with ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf23/K230206.pdf

March 24, 2023 Gravitas Medical, Inc. Saheel Sutaria Chief ...

It can be concluded that the Entarik Feeding Tube System is as safe and effective as the predicate device for the intended use, and is ...

8.

gravitasmedinc.com

gravitasmedinc.com/wp-content/uploads/IFU-04-1403-Rev-A-Gravitas-Entarik-Feeding-Tube.pdf

Entarik Feeding Tube - Operator's Manual

CAUTION: The Entarik Feeding Tube and Entarik Feeding Tube System are only intended for use by a physician, or on the order of a physician.

9.

nature.com

nature.com/articles/s41598-025-20821-0

A novel neonatal feeding tube with real time placement ...

Here, we placed Gravitas FT in neonates and collected baseline temperature and impedance data during the process of placement. There was no real ...