TERMINATED

Entarik Feeding Tube System Placement in Adult ICU

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Conditions

Nasogastric Tube

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Entarik Feeding Tube System Placement in Adult ICU

Quick Facts

Study Start:2023-05-30
Study Completion:2025-01-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05884216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Must be able to swallow tabletsAt least 18 years old
  2. * Able to provide informed consent or ability to have a legally authorized representative provide informed consent
  3. * 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.
  4. * Suitable to start enteral (gastric but no post-pyloric) feeding
  5. * 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.
  1. * 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
  2. * Known major upper airway malformation
  3. * Known major GI abnormality, upper GI malignancy, or partial gastric resection
  4. * History of gastroparesis
  5. * Currently pregnant
  6. * NPO status - expected to remain NPO for the following 72 hours.
  7. * 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
  8. * Critically ill, facing imminent death
  9. * Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination

Contacts and Locations

Study Locations (Sites)

Nova Clinical Research at HCA Florida Blake Hospital
Bradenton, Florida, 34209
United States
HCA Chippenham and Johnston-Willis Medical Center
Richmond, Virginia, 23225
United States

Collaborators and Investigators

Sponsor: Gravitas Medical, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-30
Study Completion Date2025-01-23

Study Record Updates

Study Start Date2023-05-30
Study Completion Date2025-01-23

Terms related to this study

Additional Relevant MeSH Terms

  • Nasogastric Tube