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Clinical Trials in the USA / NCT06760572
Recruiting Not applicable

Airway Data Collection With the Entarik Feeding Tube System

NCT06760572 · tracked via the Priya Life Science USA tracker
Sponsor
Theranova, L.L.C
Phase
Not applicable
Started
2025-02-13
Last updated
2025-05-13

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

Airway insertion

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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 sites (1)

FacilityCityRegionStatus
Temple University Hospital Philadelphia Pennsylvania Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06760572 on ClinicalTrials.gov ↗ ← All trials in the USA