Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429709
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-04-16
Brief Title:
Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Utility of Advanced Ultrasound Otoscope In The Diagnosis of Acute Otitis Media
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 childs 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 ie 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 11000th of the ultrasound power used for fetal imaging which is considered safe
After informed consent from a parent or guardian is obtained ultrasound and visual data will be collected for each of the childs 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 ie 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 11000th of the ultrasound power used for fetal imaging which is considered safe
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None