Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM

Recruiting

• Conditions: Otitis Media Recurrent; Ear Infection; Middle Ear Infection
• Interventions: Device: Advanced Ultrasound Otoscope

• Registration Number: NCT06429709
• Lead Sponsor: Baylor College of Medicine

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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-05-23
• Study First Posted: 2024-05-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clinical Validation	Advanced Ultrasound Otoscope	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.
Algorithm Development	Advanced Ultrasound Otoscope	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

Primary Outcome Measures

Name	Time	Method
Device Performance	2 years and 6 months	Correlations of device measurements and ultrasound data for Noninfected fluid and Bacterial Fluid to the gold standard of surgeon's findings at myringotomy.

Secondary Outcome Measures

Name	Time	Method
Device Usability	1 year	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).

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States