HealthyHealthy volunteersDevice
What this study is
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.
What's being tested
- Airway insertion
Intervention · DEVICE
Tube will be inserted into the trachea to make airway data measurements.
Study details
- Sponsor
- Theranova, L.L.C.
- Conditions
- Healthy
- Enrolling
- 30 people
- Starts
- 2025-02-13
- Est. completion
- 2025-12-12
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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1
Study locations (1)
1 openTemple University Hospital
Philadelphia, Pennsylvania, United States
- Sudhir Bolla · Contact215-707-8113Sudhir.Bolla@tuhs.temple.edu
- Gerard Criner, MD · Principal investigator
Recruiting
Study team
Sponsor
Theranova, L.L.C.
Study ID CRD-04-1877-01
Study director
Daniel Burnett, MD
Theranova, LLC
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.