Airway Data Collection With the Entarik Feeding Tube System

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-13

Study Completion Date

2025-12-12

Brief Summary

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The purpose of this study is to evaluate the airway detection performance of the Entarik Feeding Tube System, and to collect data when the Entarik Feeding Tube is in the Airway for device development.

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Detailed Description

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The study is a prospective, single center, non-blinded, single arm study. Subjects who are scheduled to undergo an elective bronchoscopy procedure will have an Entarik Feeding Tube placed into the airway through an endotracheal tube under direct visualization while temperature and impedance data are collected by the Entarik monitor. Other data will be passively simultaneously collected through the Feeding Tube.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Healthy Adults

Airway insertion

Group Type EXPERIMENTAL

Airway insertion

Intervention Type DEVICE

Tube will be inserted into the trachea to make airway data measurements.

Interventions

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Airway insertion

Tube will be inserted into the trachea to make airway data measurements.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. At least 18 years old.
2. Able to provide informed consent.
3. Adults scheduled to undergo a bronchoscopy procedure who will be intubated as part of the standard of care.

Exclusion Criteria

1. Known major upper airway malformation.
2. Presence of clinically significant respiratory infection.
3. Known bleeding disorder.
4. Currently pregnant.
5. Current basilar skull fracture.
6. Known sensitivities or allergies to the feeding tube components.
7. Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes