Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM

Ear Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06429709
• Other study ID #: H-50018
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: August 2024

Study information

• Verified date: May 2024
• Source: Baylor College of Medicine
• Contact: Rachel Arp
• Phone: 936-267-7707
• Email: rearp[@]texaschildrens.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Ear Infection
• Infections
• Middle Ear Infection
• Otitis
• Otitis Media
• Otitis Media Recurrent

Intervention

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

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	OtoNexus Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Performance	Correlation of device measurements to the gold standard of surgeon's findings at myringotomy. Gather ultrasound data for the four disease states of middle ear effusion (normal, viral infection, bacterial infection, and Adhesive Otitis Media) and correlate the ultrasound waveforms with the surgeon's findings and lab analysis obtained at tympanostomy tube insertion. For estimation of fluid character, the middle ear fluid will be correlated with the surgeon's semiquantitative grading of middle ear fluid. For the analysis of microbiota, the middle ear effusion fluid will be sent to microbiology.	2 years and 6 months
Secondary	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