40 Participants Needed

Entarik Feeding Tube for Healthy Adults

Do
Overseen ByDirector of Clinical
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Gravitas Medical, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Entarik Feeding Tube treatment?

The research on similar systems like the Cortrak Enteral access system shows that these feeding tubes can be effectively placed in patients, with a high success rate of 83% in positioning the tube correctly. This suggests that the Entarik Feeding Tube might also be effective in ensuring proper nutrition delivery.12345

Is the Entarik Feeding Tube generally safe for use in humans?

The use of enteral feeding tubes, like nasogastric tubes, is generally considered safe, but complications can occur, such as misplacement leading to serious issues like aspiration pneumonia. Safety practices and guidelines are in place to minimize these risks.678910

How is the Entarik Feeding Tube treatment different from other feeding tube treatments?

The Entarik Feeding Tube is unique because it is designed for healthy adults, unlike most feeding tubes which are typically used for patients with specific medical conditions or nutritional deficiencies. This treatment may offer a novel approach to nutritional support in a population that does not traditionally require tube feeding.411121314

What is the purpose of this trial?

In this single-site study, data will be recorded during nasogastric or orogastric placement (and post-pyloric placement) and removal of the Entarik Feeding Tube. Data will also be collected prior to, during, and following the delivery of a meal through the feeding tube.

Research Team

TS

Thomas Sorrentino, MD

Principal Investigator

Eligibility Criteria

This trial is for healthy adults over 18 who can consent and follow study procedures. They must not eat for at least 8 hours before the study starts. People with feeding tube issues, certain esophageal or gastric conditions, skull fractures, pregnancy, or deemed unsuitable by a physical exam cannot join.

Inclusion Criteria

Able to provide informed consent
Confirmed fasted state for a minimum of 8 hours prior to study initiation
I am willing and able to follow all study-related instructions.

Exclusion Criteria

Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
Self-reports pregnancy
I cannot have a feeding tube.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

Treatment

Data recorded during nasogastric or orogastric placement and removal of the Entarik Feeding Tube, and during meal delivery through the tube

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day

Treatment Details

Interventions

  • Entarik System
Trial Overview The study tests the Entarik Feeding Tube's placement and removal process in either the nose or mouth to beyond the stomach. It also examines how well it delivers a meal to participants.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Healthy AdultsExperimental Treatment1 Intervention
An Entarik feeding tube will be introduced and subjects will receive a meal administered through the feeding tube. Ultrasound and other data will be recorded before, during and after the meal is administered.

Entarik System is already approved in United States, European Union for the following indications:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Entarik System for:
  • Nutritional support for patients unable to ingest food orally
๐Ÿ‡ช๐Ÿ‡บ
Approved in European Union as Entarik System for:
  • Enteral nutrition for patients with dysphagia or inability to swallow

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gravitas Medical, Inc.

Lead Sponsor

Trials
4
Recruited
280+

Theranova, L.L.C.

Industry Sponsor

Trials
14
Recruited
540+

Findings from Research

The Cortrak Enteral Access System (CEAS) successfully placed nasojejunal tubes in 83% of patients in an ICU setting, demonstrating its effectiveness for ensuring enteral nutrition despite challenges like decreased gastric emptying.
Using the CEAS for tube placement took about 30 minutes and allowed for enteral feeding to continue for 2 to 15 days, highlighting its potential as a cost-effective and efficient method for delivering nutrition in critically ill patients.
An evaluation of the Cortrak Enteral access system in our intensive care.Dolan, AM., O'Hanlon, C., O'Rourke, J.[2019]
The CORTRAK enteral access system (CEAS) was successfully used to place nasojejunal feeding tubes in all 56 critically ill patients, including those with low platelet counts and anticoagulation therapy, indicating its efficacy and safety in challenging clinical situations.
While epistaxis (nosebleeds) occurred in 48.2% of patients, most cases were mild, and no severe bleeding complications were reported, suggesting that CEAS can be safely used even in patients with thrombocytopenia.
The feasibility of electromagnetic sensing aided post pyloric feeding tube placement (CORTRAK) in patients with thrombocytopenia with or without anticoagulation on the intensive care unit.Stecher, SS., Barnikel, M., Drolle, H., et al.[2022]
In a study of 288 adult patients receiving feeding tubes, 30% died within 6 months, and many experienced significant medical complications, such as decubitus ulcers and pneumonia, highlighting the risks associated with tube feeding.
Surrogates had high expectations for quality of life improvements from tube feeding, anticipating a rise from a baseline score of 4.6 to 8.0, but actual outcomes showed little change in daily living activities and overall quality of life, indicating a disconnect between expectations and reality.
Expectations and outcomes of gastric feeding tubes.Carey, TS., Hanson, L., Garrett, JM., et al.[2015]

References

An evaluation of the Cortrak Enteral access system in our intensive care. [2019]
The feasibility of electromagnetic sensing aided post pyloric feeding tube placement (CORTRAK) in patients with thrombocytopenia with or without anticoagulation on the intensive care unit. [2022]
Expectations and outcomes of gastric feeding tubes. [2015]
The effect of nutritional supplementation on survival in seriously ill hospitalized adults: an evaluation of the SUPPORT data. Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments. [2020]
Blenderized Tube Feedings for Adult Patients on Home Enteral Nutrition: A Pilot Study. [2019]
Nasal Feeding Tubes Are Associated with Fewer Adverse Events than Feeding via Ostomy in Hospitalized Patients Receiving Enteral Nutrition. [2023]
Nasogastric/nasoenteric tube-related adverse events: an integrative review. [2021]
"Nutrothorax" complicating a misplaced nasogastric feeding tube in a severely ill patient. [2020]
Nutrition: safe practice in adult enteral tube feeding. [2011]
10.United Statespubmed.ncbi.nlm.nih.gov
A multidisciplinary QA program for enteral nutrition in high-risk patients. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Home tube feeding for long-term nutritional support. [2017]
Solving the problem of weight control for tube-fed patients. [2017]
13.United Statespubmed.ncbi.nlm.nih.gov
Establishing early enteral nutrition with the use of self-advancing postpyloric feeding tube in critically ill children. [2012]
The nutritional status of elderly bed-ridden patients receiving tube feeding. [2019]
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