Pilot Study of the Entarik System With Advanced Functionality in Health Adults
Gravitas Medical, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
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
Interventions
- DeviceFeeding tube (Entarik)
Feeding tube placement will be verified using multiple methods in the duodenum and stomach.
Location
- Gravitas Medical, Inc.Berkeley, California