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Recruiting NCT06660758

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

No phase Interventional Healthy Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Feeding tube (Entarik).
Who it may be relevant to
Registry conditions: Healthy Adults. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Gravitas Medical, Inc. — Berkeley

Identifiers

NCT: NCT06660758 · CRD-04-1934-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗