Entarik Feeding Tube System Placement in Adult ICU

Not Applicable

Recruiting

• Conditions: Nasogastric Tube
• Interventions: Device: Entarik Feeding Tube System without monitoring; Device: Entarik Feeding Tube System

• Registration Number: NCT05884216
• Lead Sponsor: Gravitas Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-05-22
• Study Start: 2023-05-30
• Study First Posted: 2023-06-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Entarik Feeding Tube System without monitoring	Entarik Ft placement placement not guided with monitor
Entarik	Entarik Feeding Tube System	Entarik FT System guided placement

Primary Outcome Measures

Name	Time	Method
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.	1 year	All patients will receive placement verification per institutional standard of care.

Trial Locations

Locations (2)

Nova Clinical Research at HCA Florida Blake Hospital; 🇺🇸 Bradenton, Florida, United States

HCA Chippenham and Johnston-Willis Medical Center; 🇺🇸 Richmond, Virginia, United States