Entarik Feeding Tube System for Airway Data Collection in Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how effectively the Entarik Feeding Tube System detects its presence in the airway, a crucial factor for improving the device. The study involves healthy adults undergoing bronchoscopy (a test to examine the lungs) and intubation (insertion of a tube into the airway) as part of their care. It suits individuals scheduled for bronchoscopy who meet specific health criteria, such as not having major airway issues or current respiratory infections. As an unphased trial, this study allows participants to contribute to the development of safer medical devices.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on active anticoagulation therapy (blood thinners), you may be deemed unsuitable for the study.
What prior data suggests that the Entarik Feeding Tube System is safe for airway data collection in healthy subjects?
Research has shown that feeding tubes, such as the Entarik Feeding Tube System, have known safety concerns. A study of over 2,000 feeding tube insertions found that these procedures can be done safely with the right steps. However, incorrect placement can lead to problems. Another study discovered that about 10% of tube placements were not safe for feeding. In some cases, tubes ended up in the lungs instead of the stomach and required removal. While these issues are serious, following improved safety steps can greatly reduce risks.12345
Why are researchers excited about this trial?
Researchers are excited about the Entarik Feeding Tube System because it offers a novel method for airway data collection in healthy subjects. Unlike traditional feeding tubes, which are primarily used for nutrition, this system is designed to gather detailed airway information efficiently and non-invasively. The innovative design allows for precise data collection, which could improve our understanding of airway dynamics and lead to advancements in respiratory care.
What evidence suggests that the Entarik Feeding Tube System is effective for airway data collection?
Research has shown that the Entarik Feeding Tube System effectively checks if a tube is correctly placed in the airway. In a previous study, an X-ray confirmed the system's results, which is the most accurate method available. This confirmation indicates the system reliably ensures proper tube placement. The FDA has approved the device, indicating it meets safety and effectiveness standards. These findings suggest that the Entarik Feeding Tube System can enhance the safety and accuracy of medical procedures involving airway management.678910
Who Is on the Research Team?
Daniel Burnett, MD
Principal Investigator
Theranova, LLC
Are You a Good Fit for This Trial?
This trial is for healthy individuals who can participate in a study to evaluate the performance of a new feeding tube system called Entarik. Specific eligibility criteria are not provided, so general good health seems to be the main requirement.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Procedure
Entarik Feeding Tube is placed into the airway through an endotracheal tube under direct visualization while data is collected
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Interventions
- Entarik Feeding Tube System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Theranova, L.L.C.
Lead Sponsor
National Institute on Aging (NIA)
Collaborator