Testing the Entarik Feeding Tube in Healthy Adults
Pilot Study of the Entarik System With Advanced Functionality in Health Adults
This study is testing how well the Entarik Feeding Tube works when it's put in and taken out in healthy adults during a meal.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Gravitas Medical, Inc. Industry-sponsored |
| Locations | 1 site (Berkeley, California) |
| Trial ID | NCT06660758 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates the Entarik Feeding Tube's functionality during its placement and removal in healthy adults. Data will be collected before, during, and after the delivery of a meal through the tube to assess its performance. The study aims to gather insights on the tube's usability and effectiveness in a controlled environment. Participants will be monitored for their ability to follow study procedures and provide informed consent.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 and older who can provide informed consent and are in a fasted state prior to the study.
Not a fit: Patients with conditions that prevent the use of a feeding tube, such as esophageal strictures or gastric ulcers, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the design and functionality of feeding tubes, improving patient care in clinical settings.
How similar studies have performed: While this study is focused on a specific feeding tube, similar studies evaluating feeding tube functionality have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berkeley, California
- Gravitas Medical, Inc. — Berkeley, California, United States (Recruiting)
Study contacts
- Principal investigator: Thomas Sorrentino, MD
- Study coordinator: Director of Clinical
- Email: clinicalstudy@theranova.com
- Phone: 415-926-8616
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.