110
Participants
Start Date
May 30, 2023
Primary Completion Date
September 30, 2026
Study Completion Date
December 31, 2026
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."
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."
RECRUITING
HCA Chippenham and Johnston-Willis Medical Center, Richmond
NOT_YET_RECRUITING
Nova Clinical Research at HCA Florida Blake Hospital, Bradenton
Lead Sponsor
Gravitas Medical, Inc.
INDUSTRY