Airway Data Collection With the Entarik Feeding Tube System

May 7, 2025 updated by: Theranova, L.L.C.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital
        • Principal Investigator:
          • Gerard Criner, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Adults
Airway insertion
Device: Airway insertion
Tube will be inserted into the trachea to make airway data measurements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of accurate airway verifications by the Entarik feeding tube system
Time Frame: 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.
During the airway placement procedure
Incidence of Adverse Events
Time Frame: 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.
During the airway placement procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Theranova, L.L.C.

Collaborators

National Institute on Aging (NIA)

Investigators

  • Study Director: Daniel Burnett, MD, TheraNova, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2025

Primary Completion (Estimated)

December 12, 2025

Study Completion (Estimated)

December 12, 2025

Study Registration Dates

First Submitted

December 31, 2024

First Submitted That Met QC Criteria

December 31, 2024

First Posted (Actual)

January 7, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 7, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CRD-04-1877-01
  • R44AG076248 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Demographics and Primary Endpoint results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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