OtoNexus Novoscope Evaluation - Clinical Trial
What is the Purpose of this Study?
This study will happen during a child’s visit to the emergency room. There will be no extra visits after this. A doctor will first check the ears like normal and share their opinion. Then the doctor will use the Novoscope. The tip of the Novoscope will go into the outer ear, just like a regular ear check. The eardrum will get a soft puff of air, and the doctor will record an ultrasound reading. Collecting readings takes only 1 to 2 minutes for each ear. The whole study will take about 20 to 30 minutes.
The study is very safe. The risks are no greater than a regular ear exam.
OtoNexus Medical Technologies is making a new tool to help doctors find ear infections in children. This tool is called the Novoscope. It can tell if there is fluid behind the eardrum and what kind of fluid it is. It may even show if the infection is caused by bacteria or a virus.
Who Can Participate in the Study?
Children and teens who come to the Duke emergency room with possible ear infections may be asked to join this study. Kids up to 17 years old can take part. A research team member will talk to parents or guardians about the study. For children 6 and younger, parents give permission. For kids ages 7 to 17, parents give permission and the child must also agree.
Some children may not be able to join if the doctor thinks they are not good candidates, such as if they have ear tubes with a lot of scarring that could affect the exam.
What is Involved?
The goal of this study is to learn more about children’s eardrums so the Novoscope can work better. By using this information, the device will become more accurate and helpful for doctors when they check for ear infections. This will also help make future versions of the device even better for children and families.
Study Details
