Airway Data Collection With the Entarik Feeding Tube System

TheraNova

Status: Enrolling

Conditions: Healthy

Treatments: Device: Airway insertion

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06760572

CRD-04-1877-01

R44AG076248 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Healthy Adults

Experimental group

Description:

Airway insertion

Treatment:

Device: Airway insertion