Recruiting

Entarik System

Sponsor:

Gravitas Medical, Inc.

Code:

NCT06660758

Conditions

Healthy Adults

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Feeding tube (Entarik)

Study Details

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.

Conditions

Healthy Adults

Study ID

NCT06660758

Start date

Oct 22, 2024

Status verified date

Jul, 2025

Completion date

Dec 22, 2025

Anticipated

Primary completion date

Dec 21, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Healthy Adults

An Entarik feeding tube will be introduced and subjects will receive a meal administered through the feeding tube. Ultrasound and other data will be recorded before, during and after the meal is administered.

Interventions

Feeding tube (Entarik)

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

Primary outcome measure

  • Freedom from device-related adverse events [ Time Frame: From enrollment to end of study (1 day) ]

Central Contacts and Locations

Central contacts

Director of Clinical

415-926-8616clinicalstudy@theranova.com

Locations

Gravitas Medical, Inc.

Recruiting

Berkeley, California, United States, 94710

Contacts

Aaron Miller

415-926-8616clinicalstudy@theranova.com

Principal Investigator:

Thomas Sorrentino, MD

More Information

Sponsor

Gravitas Medical, Inc.

Last update posted

Jul 11, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gravitas Medical, Inc. on 2025-07-11.