Airway Data Collection With the Entarik Feeding Tube System

Not Applicable

Recruiting

• Conditions: Healthy

• Registration Number: NCT06760572
• Lead Sponsor: Theranova, L.L.C.

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.

Study Timeline

• Study First Submitted: 2024-12-31
• Study First Submitted QC: 2024-12-31
• Study First Posted: 2025-01-07
• Study Start: 2025-02-13
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Primary Completion: 2025-12-12
• Study Completion: 2025-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Temple University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States