Entarik Feeding Tube System Placement in Adult ICU

Stopped early · Not applicable

Conditions studied: Nasogastric Tube

In brief

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 administration of nutrition, fluids and medications.

Key facts

Study ID

NCT05884216

Run by

Gravitas Medical, Inc.

People needed

45

Starts

2023-05-30

Expected to finish

2025-01-23

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must be able to swallow tabletsAt least 18 years old
• Able to provide informed consent or ability to have a legally authorized representative provide informed consent
• Adults in the ICU requiring an 8Fr, 10Fr, or 12Fr NG tube. The size of the feeding tube should be determined clinically, and the Entarik Feeding Tube should only be placed if that size is appropriate.
• Suitable to start enteral (gastric but no post-pyloric) feeding
• Anticipated to receive enteral feeding (either bolus or continuous feeds) for more than 6 hours and conclude the enteral nutrition while in the care of the ICU. If enteral nutrition has already been initiated, indicated for replacement of an NG feeding tube Note: Both subjects on a ventilator (non-invasive or invasive ventilation) or not requiring a ventilator are eligible for this study.

You may not qualify if…

• inability to receive a feeding tube including subjects with known history of issues such as esophagitis or strictures, frequent nose bleeds, basilar skull fracture or GI bleeding disorders
• Known major upper airway malformation
• Known major GI abnormality, upper GI malignancy, or partial gastric resection
• History of gastroparesis
• Currently pregnant
• NPO status - expected to remain NPO for the following 72 hours.
• Patient needs an MRI in the immediate future (e.g., 6-12h) where placement of the feeding tube (non-MRI compatible) is going to mandate replacement with standard feeding tube
• Critically ill, facing imminent death
• Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination

Where it is running

• Nova Clinical Research at HCA Florida Blake Hospital — Bradenton, Florida, United States
• HCA Chippenham and Johnston-Willis Medical Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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