Healthy Adults
Conditions
Brief 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.
Interventions
DEVICEFeeding tube (Entarik)
Feeding tube placement will be verified using multiple methods in the duodenum and stomach.
Sponsors
Theranova, L.L.C.
Gravitas Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from device-related adverse events | From 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. |
Countries
United States
Contacts
Primary ContactDirector of Clinical
Outcome results
None listed