Entarik Feeding Tube System Placement in Adult ICU

Gravitas Medical

Status: Terminated

Conditions: Nasogastric Tube

Treatments: Device: Entarik Feeding Tube System; Device: Entarik Feeding Tube System without monitoring

Study type: Interventional

Funder types: Industry

Identifiers

NCT05884216

CRD-04-1642-01

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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, 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Entarik

Experimental group

Description:

Entarik FT System guided placement

Treatment:

Device: Entarik Feeding Tube System

Control

Active Comparator group

Description:

Entarik Ft placement placement not guided with monitor

Treatment:

Device: Entarik Feeding Tube System without monitoring