Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06429709 |
Other study ID # |
H-50018 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 1, 2021 |
Est. completion date |
August 2024 |
Study information
Verified date |
May 2024 |
Source |
Baylor College of Medicine |
Contact |
Rachel Arp |
Phone |
936-267-7707 |
Email |
rearp[@]texaschildrens.org |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The objective of this study is to collect ultrasound signal information and visual otoscopic
images with an engineering prototype device for children scheduled for tympanostomy tube
surgery for the purpose of algorithm development.
Description:
The objective of this study is to collect ultrasound signal information and visual otoscopic
images with an engineering prototype device for children scheduled for tympanostomy tube
surgery for the purpose of algorithm development.
After informed consent from a parent or guardian is obtained, ultrasound and visual data will
be collected for each of the child's ears. The images will be taken with the Advanced
Ultrasound Otoscope device. The ear laterality will be noted as well as any infection present
in the fluid, non-infected fluid, or normal findings in the middle ear as reported by the
surgeon. No identifiable data will be recorded. Each study participant will be given a unique
study number that will be linked to the images and middle ear findings. No additional
information is gathered including age, sex, name or other PHI. The images and corresponding
study data will be stored on a password protected smartphone or tablet as well as on a
password protected external hard drive. Other characteristics that will be collected include
surgical and lab findings regarding effusion, presence or absence (i.e. effusion). The middle
ear fluid which is usually suctioned will be collected in a trap chamber- Tympap- and this
collected fluid will be sent to the microbiology laboratory for analysis
Investigators will be collecting ultrasound and visual data from the tympanic membrane. The
images the investigators are collecting are optical images of the surface of the tympanic
membrane. The waveforms do not traverse the body tissue, the tympanic membrane is a strong
reflector, and the signal is returned to the ultrasound transducer for processing the
waveform from an analog to a digital signal. The power of the ultrasound signal is 1/1000th
of the ultrasound power used for fetal imaging which is considered safe.