Entarik Feeding Tube for Healthy Adults

Overseen By Director of Clinical

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Gravitas Medical, Inc.

Disqualifiers: Hiatal hernia, Esophagitis, Pregnancy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

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.

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{7 11 12 13 14}

Who Is on the Research Team?

Thomas Sorrentino, MD

Principal Investigator

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Healthy Adults Experimental Treatment 1 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:

Approved in United States as Entarik System for:

• Nutritional support for patients unable to ingest food orally

Approved in European Union as Entarik System for:

• Enteral nutrition for patients with dysphagia or inability to swallow

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expectations and outcomes of gastric feeding tubes. Carey, TS., Hanson, L., Garrett, JM., et al.[2015]

In a study of 6298 seriously ill hospitalized adults, enteral feeding significantly improved survival rates for patients in a coma, indicating its potential benefit in this specific condition.

However, nutritional support, particularly enteral tube feeding and hyperalimentation, was linked to decreased survival in patients with acute respiratory failure, cirrhosis, and chronic obstructive pulmonary disease (COPD), suggesting that artificial nutrition may not be beneficial for all critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Borum, ML., Lynn, J., Zhong, Z., et al.[2020]

In a pilot study involving 20 adult participants at the Mayo Clinic, blenderized tube feeding (BTF) was shown to be safe and effective, with 6 out of 9 participants experiencing weight gain after 6 weeks of use.

The frequency of BTF use increased significantly over the study period, with more participants consuming over 50% of their calories from BTF by the end of the 6 weeks, indicating a growing acceptance and potential for this alternative to commercial enteral nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blenderized Tube Feedings for Adult Patients on Home Enteral Nutrition: A Pilot Study. Hurt, RT., Epp, LM., Duellman, WM., et al.[2019]

In a study of 226 hospitalized patients over 9 weeks, surgical feeding tubes were found to have a significantly higher rate of adverse events (3.34 per 100 subject days) compared to natural orifice feeding tubes (1.25 per 100 subject days), indicating they may be less safe.

Only 50% of the adverse events were documented in medical records, suggesting that the actual incidence of complications may be even higher, and highlighting the need to reevaluate policies that mandate surgical feeding ostomies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal Feeding Tubes Are Associated with Fewer Adverse Events than Feeding via Ostomy in Hospitalized Patients Receiving Enteral Nutrition. Bowman, CA., Hutchins, E., Burgermaster, M., et al.[2023]

A review of 69 studies found that adverse events related to nasogastric/nasoenteric tubes are common, with a significant number leading to respiratory complications, increased hospital stays, and even death.

The findings highlight the need for healthcare professionals, particularly nurses, to create evidence-based guidelines for the safe insertion and positioning of these tubes to minimize risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasogastric/nasoenteric tube-related adverse events: an integrative review. Motta, APG., Rigobello, MCG., Silveira, RCCP., et al.[2021]

The introduction of nasogastric feeding tubes, while generally considered safe, carries a complication rate of 0.3 to 15%, primarily due to misplacement into the trachea, which can lead to severe outcomes like aspiration pneumonia and even death in 0.1-0.3% of cases.

In a specific case involving a 61-year-old female, misplacement of a nasogastric tube resulted in a rare but serious complication known as 'nutrothorax,' where enteral nutrition fluid accumulated in the pleural space, highlighting the potential dangers of this common procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Nutrothorax" complicating a misplaced nasogastric feeding tube in a severely ill patient. Felipe-Silva, A., de Campos, FPF.[2020]

Enteral feeding tubes, like nasogastric and gastrostomy tubes, are generally safe and effective for providing nutrition to patients, but recent alerts from the National Patient Safety Agency (NPSA) have prompted a review of best practices.

The article emphasizes the importance of adhering to updated guidelines to prevent complications associated with enteral feeding, such as ensuring proper measurement and administration of liquid medicines and detecting issues early after gastrostomy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition: safe practice in adult enteral tube feeding. Fletcher, J.[2011]

A multidisciplinary peer review committee identified significant complications associated with nasogastric feeding tubes, including lung perforations and aspiration pneumonia, particularly in high-risk patients such as those on ventilators.

The committee established a credentialing process for healthcare providers involved in feeding tube placement and emphasized the need for improved medical management and ongoing education to enhance the safety and efficacy of enteral feeding in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multidisciplinary QA program for enteral nutrition in high-risk patients. D'Addario, V., Danek, M.[2019]

Outpatient tube feeding significantly improved nutritional intake in 23 adult patients with protein-calorie malnutrition, providing an average of 78.5 g of protein and 2248 calories per day, compared to their previous diet which only provided 35.2 g of protein and 844 calories.

Patients on tube feeding experienced increases in serum albumin and total body weight, and the method was found to be safe and effective, with no major complications reported during the process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home tube feeding for long-term nutritional support. Newmark, SR., Simpson, MS., Beskitt, MP., et al.[2017]

Fresubin1000 Complete is a new enteral tube feed that provides all necessary nutrients, including fiber, in just 1000 kcal per liter, making it suitable for patients with low energy needs or those who are overweight.

This product addresses the challenge of ensuring complete nutrition while reducing caloric intake, as it is designed to meet all vitamin, mineral, and trace element requirements without exceeding energy needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solving the problem of weight control for tube-fed patients. Kemp, S.[2017]

In a case series of 7 critically ill pediatric patients, a 14Fr polyurethane self-advancing jejunal feeding tube was successfully placed at the bedside within 24 hours, allowing for early enteral nutrition (EN) without the need for endoscopic intervention.

All patients achieved their nutritional goals within 48 hours of tube placement, demonstrating that this method can effectively support early EN and reduce the need for parenteral nutrition in children who cannot tolerate gastric feeds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing early enteral nutrition with the use of self-advancing postpyloric feeding tube in critically ill children. Khlevner, J., Antino, J., Panesar, R., et al.[2012]

In a study of 44 hospitalized bed-ridden patients over 65 years old, those receiving tube feeding had significantly lower body weight, body mass index, and serum albumin levels compared to age-matched free-eating elders, indicating a higher risk of malnutrition.

Despite receiving adequate energy and protein intake through tube feeding, the incidence of protein malnutrition was notably higher in tube-fed patients, highlighting the need for improved nutritional management strategies for bed-ridden individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The nutritional status of elderly bed-ridden patients receiving tube feeding. Okada, K., Yamagami, H., Sawada, S., et al.[2019]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

An evaluation of the Cortrak Enteral access system in our intensive care. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

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]

3. United States pubmed.ncbi.nlm.nih.gov

Expectations and outcomes of gastric feeding tubes. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

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]

5. United States pubmed.ncbi.nlm.nih.gov

Blenderized Tube Feedings for Adult Patients on Home Enteral Nutrition: A Pilot Study. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Nasal Feeding Tubes Are Associated with Fewer Adverse Events than Feeding via Ostomy in Hospitalized Patients Receiving Enteral Nutrition. [2023]

7. Brazil pubmed.ncbi.nlm.nih.gov

Nasogastric/nasoenteric tube-related adverse events: an integrative review. [2021]

8. Brazil pubmed.ncbi.nlm.nih.gov

"Nutrothorax" complicating a misplaced nasogastric feeding tube in a severely ill patient. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Nutrition: safe practice in adult enteral tube feeding. [2011]

10. United States pubmed.ncbi.nlm.nih.gov

A multidisciplinary QA program for enteral nutrition in high-risk patients. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Home tube feeding for long-term nutritional support. [2017]

12. England pubmed.ncbi.nlm.nih.gov

Solving the problem of weight control for tube-fed patients. [2017]

13. United States pubmed.ncbi.nlm.nih.gov

Establishing early enteral nutrition with the use of self-advancing postpyloric feeding tube in critically ill children. [2012]

14. Japan pubmed.ncbi.nlm.nih.gov

The nutritional status of elderly bed-ridden patients receiving tube feeding. [2019]