NCT06660758NARecruitingAccepts Healthy Volunteers
Pilot Study of the Entarik System With Advanced Functionality in Health Adults
Gravitas Medical, Inc.
Start Date
10/22/2024
Completion Date
12/22/2025
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 Criteria
Age Range: 18 years to No maximum
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
DEVICE
Feeding tube (Entarik)
Conditions
Healthy Adults
Locations
Gravitas Medical, Inc.
Berkeley, California 94710
United States