Purpose of this Study
On the day of surgery, before the child is given anesthesia, the doctor will use a device called the Novoscope to look at the eardrum. The doctor will gently blow small puffs of air into the ear to check how the eardrum moves. This only takes about one or two minutes for each ear. During the surgery, before the ear tube is placed, the doctor will collect a small sample of fluid from the middle ear. This sample will not have the child’s name on it and will be sent to a lab for testing.
Who Can Participate?
Eligibility
Children can join this study if they are newborns up to 17 years old and are scheduled to have ear tube surgery. A parent or another legal adult must give permission for them to take part. Children cannot join if they have had past ear surgery that affects the eardrum, have problems with the eardrum or ear canal, were born with conditions that change how the ear is shaped or works, or have behavior problems that make it hard for doctors to safely examine their ears.
Age Range
0-17
Sex/Genders
Male (cisgender)
Female (cisgender)
Looking for Healthy Participants
No
What is Involved?
Description
This study is paid for by a company called OtoNexus Medical Technologies. It is testing a device called the Novoscope. The Novoscope works like a regular tool doctors use to look in the ear, but it also uses sound waves and gentle air puffs. These features help doctors check how the eardrum moves and see if there is fluid behind it. The goal of the study is to find out how well the Novoscope can tell if the fluid in the middle ear is caused by bacteria. Doctors will compare what the Novoscope shows with lab test results from ear fluid collected during surgery.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
OTONEXUS ADVANCED OTOSCOPE (NOVOSCOPE) DESIGN AND HUMAN FACTORS EVALUATION PROTOCOL
Principal Investigator
Eileen
Raynor
Protocol Number
PRO00120311
Phase
N/A
Enrollment Status
Pending Open to Enrollment