Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM

Utility of Advanced Ultrasound Otoscope In The Diagnosis of Acute Otitis Media

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Middle Ear Infection; Ear Infection; Otitis Media Recurrent
• Intervention / Treatment: Device: Advanced Ultrasound Otoscope

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: Advanced Ultrasound Otoscope; The Advanced Ultrasound Otoscope is a tool for visualization of the human tympanic membrane and detection of middle ear effusion type
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.	Device: Advanced Ultrasound Otoscope; The Advanced Ultrasound Otoscope is a tool for visualization of the human tympanic membrane and detection of middle ear effusion type

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: OtoNexus Medical Technologies, Inc.
• Investigators: Study Chair: Tiffany Raynor, MD, Baylor College of Medicine; Principal Investigator: Yi-Chun Liu, MD, Baylor College of Medicine; Study Chair: 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: Mary E Williamson, MD, Baylor College of Medicine; Study Chair: Henri Traboulsi, MD, Baylor College of Medicine; Study Chair: Anna Messner, MD, Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: April 16, 2024
• First Submitted That Met QC Criteria: May 23, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Estimated): September 11, 2025
• Last Update Submitted That Met QC Criteria: September 4, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Ultrasound; Effusion; Otoscope; Tympanogram
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: H-50018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No