Entarik Feeding Tube for Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the performance of the Entarik Feeding Tube during meal delivery. Researchers will collect data before, during, and after a meal to understand its effects and performance. Healthy adults who have no issues preventing them from receiving a feeding tube and can fast for at least 8 hours may be suitable for this study. As an unphased trial, it offers participants the chance to contribute to foundational research that could enhance future medical procedures.
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 prior data suggests that the Entarik Feeding Tube is safe for healthy adults?
Research has shown that the Entarik Feeding Tube System is generally safe and performs comparably to other similar devices. While feeding tubes are typically safe, some risks exist. For example, incorrect placement can lead to serious issues. However, no specific negative effects have been widely reported with the Entarik system itself, suggesting it is well-tolerated when used properly.12345
Why are researchers excited about this trial?
Researchers are excited about the Entarik feeding tube because it offers a new way to deliver meals directly to the stomach. Unlike traditional oral feeding methods, which rely on swallowing and digestion starting in the mouth, the Entarik System uses a feeding tube to administer nutrition directly, potentially benefiting those who have difficulty swallowing or require precise nutritional delivery. This method allows for real-time monitoring with ultrasound, offering insights into how the body processes food without the usual digestive cues. This innovative approach could lead to more personalized nutritional care and improved outcomes for individuals needing alternative feeding methods.
What evidence suggests that the Entarik Feeding Tube is effective for healthy adults?
Studies have shown that the Entarik Feeding Tube effectively places feeding tubes in patients. For instance, the Cortrak Enteral Access System, a similar system, successfully placed feeding tubes in the small intestine for 83% of ICU patients. This suggests that the Entarik Feeding Tube can reliably position feeding tubes correctly in the body. Research also indicates that the system's design aids in confirming correct placement, enhancing its effectiveness. While most studies focus on tube placement, these findings suggest it performs well for similar medical needs.34678
Who Is on the Research Team?
Thomas Sorrentino, MD
Principal Investigator
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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