Otitis Media RecurrentNCT06429709
Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM
An observational study of Otitis Media Recurrent and Middle Ear Infection, run by Baylor College of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 0 to 12 years
- Conditions the study is for
- Otitis Media Recurrent, Middle Ear Infection, Ear Infection
- What is being tested?
- Advanced Ultrasound Otoscope
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Cholesteatoma, tympanic membrane perforation, myringitis
- History of PE tube placement or PE tubes currently in place.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Otitis Media Recurrent, Middle Ear Infection, Ear Infection
- Being tested
- Advanced Ultrasound Otoscope
- Keywords
- Otoscope, Tympanogram, Effusion, Ultrasound
- Medical subject headings
- Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced Ultrasound OtoscopeDevice
The Advanced Ultrasound Otoscope is a tool for visualization of the human tympanic membrane and detection of middle ear effusion type
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Advanced Ultrasound Otoscope | |
| 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. Receives: Device: Advanced Ultrasound Otoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years and 6 months
Secondary outcomes (1)
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).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start1 Sep 2021
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media RecurrentStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- OtoNexus Medical Technologies, Inc.
- Responsible party
- Principal investigator, Yi-Chun Carol Liu, Baylor College of Medicine
- Investigators
- Yi-Chun Liu, MD, Principal investigator, Baylor College of MedicineShraddha Mukerji, MD, Study chair, Baylor College of MedicineJennifer Yan, MD, Study chair, Baylor College of MedicineSonal Saraiya, MD, Study chair, Baylor College of MedicineHenri Traboulsi, MD, Study chair, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429709
- Sponsor's protocol ID
- H-50018
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2024
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Advanced Ultrasound Otoscope In The Diagnosis of Acute Otitis Media
- ClinicalTrials.gov ID
- NCT06429709
- Acronym / sponsor ID
- H-50018
- Conditions
- Otitis Media Recurrent, Middle Ear Infection, Ear Infection
- Keywords
- Otoscope, Tympanogram, Effusion, Ultrasound
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- OtoNexus Medical Technologies, Inc.
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Algorithm Development | – | Device: Advanced Ultrasound OtoscopeUltrasound 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 | – | Device: Advanced Ultrasound OtoscopeThe 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. |
Who may qualify
- Ages
- 0 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Cholesteatoma, tympanic membrane perforation, myringitis
- History of PE tube placement or PE tubes currently in place.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced Ultrasound OtoscopeThe Advanced Ultrasound Otoscope is a tool for visualization of the human tympanic membrane and detection of middle ear effusion type | Device | Algorithm Development, Clinical Validation |
Primary outcome
Device Performance
Time frame: 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.
1 secondary outcome
Device Usability
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi-Chun Liu, MD principal investigator
Baylor College of Medicine
Shraddha Mukerji, MD study chair
Baylor College of Medicine
Jennifer Yan, MD study chair
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media Recurrent and Middle Ear Infection, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Performance (time frame: 2 years and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.