Airway Data Collection With the Entarik Feeding Tube System

Description

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.

Conditions

Healthy

Study Overview

Study Details

Study overview

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.

Airway Data Collection With the Entarik Feeding Tube System

Airway Data Collection With the Entarik Feeding Tube System

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Temple University Hospital, Philadelphia, Pennsylvania, United States, 19140

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Theranova, L.L.C.,

Daniel Burnett, MD, STUDY_DIRECTOR, Theranova, LLC

Study Record Dates

2025-12-12