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

Launched by GRAVITAS MEDICAL, INC. · Oct 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new feeding tube called the Entarik System, which is designed to help deliver nutrition to patients who cannot eat normally. The trial will take place at a single location and will involve healthy adults who are at least 18 years old. Participants will have the feeding tube placed and removed while researchers collect information about the process. They will also monitor how the tube works during a meal delivered through it.

To be eligible for this study, participants need to be able to give their consent and follow the study's procedures. They must also be in a fasted state, meaning they haven't eaten for at least 8 hours before the study starts. However, people with certain health issues, like problems with their esophagus or stomach, or those who are pregnant, cannot participate. This trial is currently recruiting participants, and those who join can expect to play a role in helping researchers understand how this feeding tube works, which could lead to improvements in how nutrition is provided in medical settings.

Gender

ALL

Eligibility criteria

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