Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06660758

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.

Recruiting

Interested in participating?

Request Info

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

Location contact

Aaron Miller

CONTACT

[email protected]

415-926-8616

Daniel Burnett, MD

SUB_INVESTIGATOR

Thomas Sorrentino, MD

PRINCIPAL_INVESTIGATOR

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

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Director of Clinical

CONTACT

[email protected]

415-926-8616

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.