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

NCT06660758 | Recruiting FDA Device

• 1 other identifier: CRD-04-1934-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Freedom from device-related adverse events

  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.

  From enrollment to end of study (1 day)

Study Arms (1)

Healthy Adults

EXPERIMENTAL

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.

Device: Feeding tube (Entarik)

Interventions

Feeding tube (Entarik) DEVICE

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

Healthy Adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gravitas Medical, Inc.: lead
• Theranova, L.L.C.: collaborator

Study Sites (1)

Gravitas Medical, Inc.

Berkeley, California, 94710, United States

RECRUITING

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Thomas Sorrentino, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Director of Clinical

CONTACT

415-926-8616; clinicalstudy@theranova.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 28, 2024
• Study Start: October 22, 2024
• Primary Completion: December 21, 2025
• Study Completion: December 22, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)