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Clinical Trials in the USA / NCT06660758
Recruiting Not applicable

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

NCT06660758 · tracked via the Priya Life Science USA tracker
Sponsor
Gravitas Medical, Inc
Phase
Not applicable
Started
2024-10-22
Last updated
2025-07-11

Condition(s) studied

Healthy Adults

Investigational drug(s) / intervention(s)

Feeding tube (Entarik)

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Freedom from device-related adverse events — 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.

Trial sites (1)

FacilityCityRegionStatus
Gravitas Medical, Inc. Berkeley California Recruiting

More Gravitas Medical, Inc. trials in the USA

Gravitas Feeding Tube System Placement Validation in Neonates Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06660758 on ClinicalTrials.gov ↗ ← All trials in the USA