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| Name | Class |
|---|---|
| OtoNexus Medical Technologies, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Algorithm Development | Ultrasound and signal information and visual otoscopic images will be collected with an engineering prototype otoscope device for children scheduled for tympanostomy tube surgery. Images of each of the child's ears will be taken by the advanced ultrasound otoscope device. Data collected will include ear laterality, surgical and lab findings of the effusion (present or absent) and characteristics as reported by the surgeon. The middle ear fluid which is usually suctioned will be collected in a trap chamber- Tympap- and this collected fluid will be send for analysis to microbiology. The pathology results will be recorded to correlate ultrasound signals to surgical findings |
| |
| Clinical Validation | The clinical validation phase includes the same procedures as the algorithm development phase only, the clinical validation phase is a double blind study where ultrasound score is compared to surgical findings and lab analysis. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Advanced Ultrasound Otoscope | Device | The Advanced Ultrasound Otoscope is a tool for visualization of the human tympanic membrane and detection of middle ear effusion type |
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| Measure | Description | Time Frame |
|---|---|---|
| Device Performance | Correlations of device measurements and ultrasound data for Noninfected fluid and Bacterial Fluid to the gold standard of surgeon's findings at myringotomy. | 2 years and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Device Usability | Evaluate the usability of the Advanced Ultrasound Otoscope device in pediatric patients as measured by the ability of the device to fit in subjects' external auditory canals and obtain a tympanic mobility measurement(s). | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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The investigators will be recruiting patients between 0 months and 12 years of age who meet the listed inclusion criteria and do not meet any of the listed exclusion criteria. The investigators are not selecting patients based on race/ethnicity or gender/sex. Parents must be fluent in either English or Spanish.
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| Name | Affiliation | Role |
|---|---|---|
| Yi-Chun Liu, MD | Baylor College of Medicine | Principal Investigator |
| Shraddha Mukerji, MD | Baylor College of Medicine | Study Chair |
| Jennifer Yan, MD | Baylor College of Medicine | Study Chair |
| Sonal Saraiya, MD | Baylor College of Medicine | Study Chair |
| Henri Traboulsi, MD | Baylor College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Children's Hospital | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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