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

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.

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Key information

Conditions

Healthy Adults

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gravitas Medical, Inc.

Berkeley, California, 94710, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

At least 18 years old
Able to provide informed consent
Capable and willing to follow all study-related procedures
Confirmed fasted state for a minimum of 8 hours prior to study initiation

Exclusion criteria

Inability to receive a feeding tube
Known self-reported history of hiatal hernia, esophagitis, esophageal strictures or gastric ulcers
Has a basilar skull fracture
Self-reports pregnancy
Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination

Treatment and study plan

Feeding tube (Entarik)

Device

Feeding tube placement will be verified using multiple methods in the duodenum and stomach.

Primary outcomes

Freedom from device-related adverse events

Time frame: 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.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Gravitas Medical, Inc.

Industry

Collaborators

Theranova, L.L.C.

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Oct 28, 2024
Registry last updated: Jul 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting