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NCT Number: NCT06760572

Airway Data Collection With the Entarik Feeding Tube System

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location status: Recruiting

Location contact

Gerard Criner, MD

PRINCIPAL_INVESTIGATOR

Sudhir Bolla

CONTACT

[email protected]

215-707-8113

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years old.
  • Able to provide informed consent.
  • Adults scheduled to undergo a bronchoscopy procedure who will be intubated as part of the standard of care.

Exclusion criteria

  • Known major upper airway malformation.
  • Presence of clinically significant respiratory infection.
  • Known bleeding disorder.
  • Currently pregnant.
  • Current basilar skull fracture.
  • Known sensitivities or allergies to the feeding tube components.
  • Deemed unsuitable for enrollment in study by the investigator based on subject's history (e.g., active anticoagulation therapy) or physical examination.

Treatment and study plan

Airway insertion

Device

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

Primary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aaron Miller

CONTACT

[email protected]

415-926-8616

Sponsors and collaborators

Lead sponsor

Theranova, L.L.C.

Industry

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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