Entarik Feeding Tube System for Airway Data Collection in Healthy Subjects

Overseen By Aaron Miller

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Theranova, L.L.C.

Must not be taking: Anticoagulation therapy

Disqualifiers: Upper airway malformation, Respiratory infection, Bleeding disorder, Pregnancy, Skull fracture, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on active anticoagulation therapy (blood thinners), you may be deemed unsuitable for the study.

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

The research on ICU nutrition support practices shows that using structured feeding protocols can improve the adequacy of nutrition support, suggesting that systems like the Entarik Feeding Tube System may help ensure patients receive the right amount of nutrition safely. ^{1 2 3 4 5}

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

The Entarik Feeding Tube System is described as inherently safe in one study, which mentions that it only removes excess fluids momentarily to prevent local distention (swelling). Another study highlights the importance of proper placement and management to avoid complications, suggesting that safety can be enhanced with team-based protocols and technology. ^{1 6 7 8 9}

How does the Entarik Feeding Tube System treatment differ from other treatments for airway data collection?

The Entarik Feeding Tube System is unique because it is designed specifically for noninvasive airway data collection during feeding, focusing on the coordination between swallowing and respiration. Unlike other methods, it aims to provide accurate respiratory information during feeding assessments, which is crucial for understanding swallowing safety and efficiency. ^{10 11 12 13 14}

What is the purpose of this trial?

The purpose of this study is to evaluate the airway detection performance of the Entarik Feeding Tube System, and to collect data when the Entarik Feeding Tube is in the Airway for device development.

Research Team

Daniel Burnett, MD

Principal Investigator

Theranova, LLC

Eligibility Criteria

This trial is for healthy individuals who can participate in a study to evaluate the performance of a new feeding tube system called Entarik. Specific eligibility criteria are not provided, so general good health seems to be the main requirement.

Inclusion Criteria

Able to provide informed consent

I am an adult scheduled for a bronchoscopy and will be intubated.

Exclusion Criteria

Currently pregnant

I have a known bleeding disorder.

I have a serious lung infection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Procedure

Entarik Feeding Tube is placed into the airway through an endotracheal tube under direct visualization while data is collected

During the procedure

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1-2 weeks

Treatment Details

Interventions

• Entarik Feeding Tube System

Trial Overview The study is testing how well the Entarik Feeding Tube System detects the airway when inserted and collects data while it's in place. This research will help improve the device.

Participant Groups

Group I: Healthy Adults Experimental Treatment 1 Intervention

Airway insertion

Who Is Running the Clinical Trial?

Theranova, L.L.C.

Lead Sponsor

Trials

14

Recruited

540+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

References

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

Colorimetric carbon dioxide detector to determine accidental tracheal feeding tube placement. [2013]

2. England pubmed.ncbi.nlm.nih.gov

Review of ICU nutrition support practices: implementing the nurse-led enteral feeding algorithm. [2016]

3. Germany pubmed.ncbi.nlm.nih.gov

The development and validation of a quality-of-life questionnaire for head and neck cancer patients with enteral feeding tubes: the QOL-EF. [2022]

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

Variables associated with feeding tube placement in head and neck cancer. [2015]

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

Does feeding tube placement predict for long-term swallowing disability after radiotherapy for head and neck cancer? [2019]

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

Enteral feeding monitor/manager. [2022]

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

A team-based protocol and electromagnetic technology eliminate feeding tube placement complications. [2011]

8. England pubmed.ncbi.nlm.nih.gov

Before-after study of a standardized ICU protocol for early enteral feeding in patients turned in the prone position. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Risks in Management of Enteral Nutrition in Intensive Care Units: A Literature Review and Narrative Synthesis. [2021]

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

Comparative review of techniques for recording respiratory events at rest and during deglutition. [2019]

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

The synchronization of respiration and swallow sounds with videofluoroscopy during swallowing. [2019]

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

Limitations of the computerized laryngeal analyzer (CLA) in the assessment of the swallowing mechanism. [2019]

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

Development of a Non-invasive Device for Swallow Screening in Patients at Risk of Oropharyngeal Dysphagia: Results from a Prospective Exploratory Study. [2020]

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

Visual Analysis of Swallowing Efficiency and Safety (VASES): A Standardized Approach to Rating Pharyngeal Residue, Penetration, and Aspiration During FEES. [2022]