Entarik Feeding Tube System Placement in Adult ICU (NCT05884216) | Clinical Trial Compass
TerminatedNot Applicable
Entarik Feeding Tube System Placement in Adult ICU
Stopped: Based on regulatory precedent for other smart feeding tubes, sufficient performance data was obtained to submit a 510(k) application with the FDA for the Entarik System.
United States45 participantsStarted 2023-05-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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, faci…
What they're measuring
1
Percentage of accurate verifications of anatomical locations of the tip of the Entarik feeding tube. The position of the feeding tube tip as processed by the Entarik placement algorithm will be compared to x-ray.