Airway Data Collection With the Entarik Feeding Tube System

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06760572

Enrollment

Registered

2025-01-07

Start date

2025-02-13

Completion date

2025-12-12

Last updated

2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Feeding Tube, feeding tube placement safety, feeding tube placement

Brief summary

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.

Detailed 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.

Interventions

DEVICEAirway insertion

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of accurate airway verifications by the Entarik feeding tube system	During the airway placement procedure	Percentage of accurate verifications of airway placement of the tip of the Entarik feeding tube at the Safety Check Depth.
Incidence of Adverse Events	During the airway placement procedure	Incidence of adverse events: (a) related to placement and (b) throughout the duration of the presence of the feeding tube within the subject.

Countries

United States

Contacts

Primary ContactAaron Miller

clinicalstudy@theranova.com415-926-8616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026