Entarik Feeding Tube for Healthy Adults
Trial Summary
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the Entarik Feeding Tube treatment?
The research on similar systems like the Cortrak Enteral access system shows that these feeding tubes can be effectively placed in patients, with a high success rate of 83% in positioning the tube correctly. This suggests that the Entarik Feeding Tube might also be effective in ensuring proper nutrition delivery.12345
Is the Entarik Feeding Tube generally safe for use in humans?
How is the Entarik Feeding Tube treatment different from other feeding tube treatments?
The Entarik Feeding Tube is unique because it is designed for healthy adults, unlike most feeding tubes which are typically used for patients with specific medical conditions or nutritional deficiencies. This treatment may offer a novel approach to nutritional support in a population that does not traditionally require tube feeding.411121314
What is the purpose of this trial?
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.
Research Team
Thomas Sorrentino, MD
Principal Investigator
Eligibility Criteria
This trial is for healthy adults over 18 who can consent and follow study procedures. They must not eat for at least 8 hours before the study starts. People with feeding tube issues, certain esophageal or gastric conditions, skull fractures, pregnancy, or deemed unsuitable by a physical exam cannot join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Data recorded during nasogastric or orogastric placement and removal of the Entarik Feeding Tube, and during meal delivery through the tube
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Entarik System
Entarik System is already approved in United States, European Union for the following indications:
- Nutritional support for patients unable to ingest food orally
- Enteral nutrition for patients with dysphagia or inability to swallow
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gravitas Medical, Inc.
Lead Sponsor
Theranova, L.L.C.
Industry Sponsor