Airway Data Collection With the Entarik Feeding Tube System

Launched by THERANOVA, L.L.C. · Dec 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new device called the Entarik Feeding Tube System. The main goal is to see how well this device can detect if it is placed in the airway, which is important for safely feeding patients. The study will collect information to help improve the device, and it will involve adults who are scheduled to have a procedure called bronchoscopy, where they will be intubated (given a breathing tube) as part of their regular medical care.

To participate in this trial, you need to be at least 18 years old and able to give your permission to join. You must also be scheduled for the bronchoscopy procedure. However, there are some reasons you might not be able to join, such as having certain breathing problems, active infections, or specific medical conditions. If you decide to participate, you’ll help researchers gather important data that could lead to improvements in how feeding tubes are used. The trial is not yet recruiting participants, but it is important to know that your safety and comfort will be prioritized throughout the study.

Gender

ALL

Eligibility criteria

• 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.