Pilot Study of the Entarik System in Healthy Adults
This study is testing a new feeding tube called the Entarik System. Researchers want to see if the Entarik System can be placed and removed safely in healthy adults. You might be able to join if you are at least 18 years old, can give informed consent, and have fasted for at least 8 hours. The main goal is to make sure there are no problems related to the device during the study, which lasts one day. The study is currently recruiting 40 healthy adults.
- Study design
- This is an interventional study involving 40 healthy adult participants. It is a single-site study, meaning it takes place at one location.
- What's involved
- You would have the Entarik feeding tube placed and removed. Researchers will also collect data before, during, and after you receive a meal through the tube.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed from enrollment until the end of the study, which is one day.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Pilot Study of the Entarik System With Advanced Functionality in Health Adults
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Thomas Sorrentino, MD · PRINCIPAL_INVESTIGATOR
Who to contact
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What this trial measures
- Freedom from device-related adverse eventsFrom enrollment to end of study (1 day)
The incidence and severity of Adverse Events (AEs) including device and procedure-related AEs and the incidence and severity of Serious Adverse Events (SAEs) will be evaluated throughout the study. Based on the non-invasive nature of the device and clinical experience gained to date, there are expected to be no SAEs nor Unanticipated Adverse Device Effects (UADEs) in the study. If any SAEs or UADEs occur they will be documented and reported, but there are no planned formal hypotheses associated with the evaluation of safety.