RECRUITING

Pilot Study of the Entarik System With Advanced Functionality in Health Adults

Conditions

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

In this single-site study, data will be recorded during nasogastric or orogastric placement (and post-pyloric placement) and removal of the Entarik Feeding Tube. Data will also be collected prior to, during, and following the delivery of a meal through the feeding tube.

Official Title

Pilot Study of the Entarik System With Advanced Functionality in Health Adults

Quick Facts

Study Start:2024-10-22
Study Completion:2025-04-22
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06660758

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:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. At least 18 years old
  2. 2. Able to provide informed consent
  3. 3. Capable and willing to follow all study-related procedures
  4. 4. Confirmed fasted state for a minimum of 8 hours prior to study initiation
  1. 1. Inability to receive a feeding tube
  2. 2. Known self-reported history of hiatal hernia, esophagitis, esophageal strictures or gastric ulcers
  3. 3. Has a basilar skull fracture
  4. 4. Self-reports pregnancy
  5. 5. Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination

Contacts and Locations

Study Contact

Director of Clinical
CONTACT
415-926-8616
clinicalstudy@theranova.com

Principal Investigator

Thomas Sorrentino, MD
PRINCIPAL_INVESTIGATOR

Study Locations (Sites)

Gravitas Medical, Inc.
Berkeley, California, 94710
United States

Collaborators and Investigators

Sponsor: Gravitas Medical, Inc.

  • Thomas Sorrentino, MD, PRINCIPAL_INVESTIGATOR

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 Date2024-10-22
Study Completion Date2025-04-22

Study Record Updates

Study Start Date2024-10-22
Study Completion Date2025-04-22

Terms related to this study

Additional Relevant MeSH Terms

  • Healthy Adults