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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-22

Study Completion Date

2025-12-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Adults

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Feeding tube (Entarik)

Intervention Type DEVICE

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

Interventions

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Feeding tube (Entarik)

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes