Clinical trial NCT06429709: Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM
Official title: Utility of Advanced Ultrasound Otoscope In The Diagnosis of Acute Otitis Media
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Otitis Media Recurrent
Middle Ear Infection
Ear Infection
Keywords: Otoscope
Tympanogram
Effusion
Ultrasound
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: OtoNexus Medical Technologies, Inc.
First posted: 2024-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* Newborn to 12 years of age
* Receiving first set of pressure equalization (PE) tubes, even if coordinated with other procedures such as adenoidectomy
* Indication for surgery includes recurrent acute otitis media, chronic otitis media with effusion, Eustachian tube dysfunction, and/or hearing loss.

Exclusion Criteria:

* Cholesteatoma, tympanic membrane perforation, myringitis
* History of PE tube placement or PE tubes currently in place.

Primary outcomes:
measure: Device Performance
timeFrame: 2 years and 6 months
Secondary outcomes:
measure: Device Usability
timeFrame: 1 year
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Tiffany Raynor, MD
role: STUDY_CHAIR
affiliation: Baylor College of Medicine
name: Yi-Chun Liu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baylor College of Medicine
name: Shraddha Mukerji, MD
role: STUDY_CHAIR
affiliation: Baylor College of Medicine
name: Jennifer Yan, MD
role: STUDY_CHAIR
affiliation: Baylor College of Medicine
name: Sonal Saraiya, MD
role: STUDY_CHAIR
affiliation: Baylor College of Medicine
name: Mary E Williamson, MD
role: STUDY_CHAIR
affiliation: Baylor College of Medicine
name: Henri Traboulsi, MD
role: STUDY_CHAIR
affiliation: Baylor College of Medicine
name: Anna Messner, MD
role: STUDY_CHAIR
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