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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adults
• Intervention / Treatment: Device: Feeding tube (Entarik)

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Director of Clinical; Phone Number: 415-926-8616; Email: clinicalstudy@theranova.com

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94710
      • Recruiting
      • Gravitas Medical, Inc.
      • Contact: Aaron Miller; Phone Number: 415-926-8616; Email: clinicalstudy@theranova.com
      • Principal Investigator: Thomas Sorrentino, MD
      • Sub-Investigator: Daniel Burnett, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Feeding tube (Entarik); Feeding tube placement will be verified using multiple methods in the duodenum and stomach.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Gravitas Medical, Inc.
• Collaborators: Theranova, L.L.C.
• Investigators: Principal Investigator: Thomas Sorrentino, MD

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2024
• Primary Completion (Estimated): December 21, 2025
• Study Completion (Estimated): December 22, 2025

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 8, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CRD-04-1934-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a device development study. Subject data may be shared at a later time at the sponsor's discretion.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No