Entarik Feeding Tube System Placement in Adult ICU

NCT ID: NCT05884216

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2025-01-23

Brief 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.

Conditions

Nasogastric Tube

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Entarik

Entarik FT System guided placement

Group Type: EXPERIMENTAL

Entarik Feeding Tube System

Intervention Type: DEVICE

Entarik Feeding Tube:

The Entarik Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

Entarik Feeding Tube System:

The Entarik Feeding Tube System is designed to aid qualified operators in the placement of the Entarik Feeding Tube (Entarik FT) into the stomach of patients requiring enteral feeding. The Entarik FT is equipped with sensors designed to provide information about the location of the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik Monitor also monitors the feeding tube position continuously during the course of feeding and automatically and in real-time alerts of tube migration.

Control

Entarik Ft placement placement not guided with monitor

Group Type: ACTIVE_COMPARATOR

Entarik Feeding Tube System without monitoring

Intervention Type: DEVICE

Entarik Feeding Tube:

The Entarik Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

Entarik Feeding Tube System:

The Entarik Feeding Tube System will collect data from the Entarik Feeding Tube. There will be no monitoring or dislodgement alerts, and no placement guidance.

Interventions

Entarik Feeding Tube System

Entarik Feeding Tube:

The Entarik Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

Entarik Feeding Tube System:

The Entarik Feeding Tube System is designed to aid qualified operators in the placement of the Entarik Feeding Tube (Entarik FT) into the stomach of patients requiring enteral feeding. The Entarik FT is equipped with sensors designed to provide information about the location of the tube tip relative to the stomach, thus assisting in reducing the incidence of misplacement during first positioning. The Entarik Monitor also monitors the feeding tube position continuously during the course of feeding and automatically and in real-time alerts of tube migration.

Intervention Type: DEVICE

Entarik Feeding Tube System without monitoring

Entarik Feeding Tube:

The Entarik Feeding Tube is intended for the administration of nutrition, fluids and medications by the nasoenteric route for patients who have an intact gastrointestinal tract but are physically unable to manage nutritional intake through normal mastication and deglutition.

Entarik Feeding Tube System:

The Entarik Feeding Tube System will collect data from the Entarik Feeding Tube. There will be no monitoring or dislodgement alerts, and no placement guidance.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gravitas Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nova Clinical Research at HCA Florida Blake Hospital

Bradenton, Florida, United States

HCA Chippenham and Johnston-Willis Medical Center

Richmond, Virginia, United States

Countries

United States

Other Identifiers

CRD-04-1642-01

Identifier Type: -

Identifier Source: org_study_id