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

Part of paid clinical trials in Berkeley, California.

Sponsor
Gravitas Medical, Inc.
Study ID
NCT06660758
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Adults

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Feeding tube (Entarik) — DEVICE
    Feeding tube placement will be verified using multiple methods in the duodenum and stomach.

Study Details

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.

Key Dates

Start date
Oct 22, 2024
Status verified
Jul 2025
Primary completion
Dec 21, 2025
Completion
Dec 22, 2025

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Gravitas Medical, Inc.BerkeleyCalifornia94710
Aaron Miller
[email protected]
415-926-8616
Thomas Sorrentino, MD (PRINCIPAL_INVESTIGATOR)
Daniel Burnett, MD (SUB_INVESTIGATOR)

Find similar trials in Berkeley, CA

By research site
Gravitas Medical, Inc.· Berkeley, CA

Related Studies