Advanced Ultrasound Otoscope for Ear Infection

Overseen By Justine Kasay

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Disqualifiers: Cholesteatoma, Tympanic membrane perforation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ultrasound otoscope device to help diagnose ear infections in children. The goal is to determine if this device can accurately match surgical findings by analyzing images and signals from the ear. Children receiving their first ear tubes due to frequent or long-term ear infections or hearing problems are eligible to join. The trial compares data from the ultrasound device with actual surgical results to develop better diagnostic tools.

As an unphased trial, this study allows participants to contribute to the development of innovative diagnostic tools for ear infections.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this advanced ultrasound otoscope is safe for children?

Research has shown that the Advanced Ultrasound Otoscope is likely very safe to use. The device's ultrasound power is only 1/1000th of what is typically used for imaging unborn babies, a level widely considered safe. Thus, the device employs very low-power ultrasound to examine the ear. Ultrasound imaging has a strong safety record, and no reports of harm have emerged from the ultrasound levels used by this device. This indicates that the treatment is well-tolerated and poses minimal risk to participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of an advanced ultrasound otoscope to diagnose acute otitis media (AOM) in children. Unlike traditional methods, which often rely on visual examination alone, this new technique combines ultrasound signals with visual otoscopic images, potentially offering a more accurate diagnosis. By comparing ultrasound scores to surgical findings and lab analysis, the study aims to establish whether this approach can enhance diagnostic precision, leading to better treatment decisions and outcomes.

What evidence suggests that the Advanced Ultrasound Otoscope is effective for tympanostomy tube surgery?

Research shows that the Advanced Ultrasound Otoscope is undergoing testing in this trial for its ability to provide clear images and signals from the ear. While direct evidence on its effectiveness in diagnosing acute otitis media (AOM) is not yet available, the device aims to enhance diagnosis by offering more detailed images than traditional methods. The goal is to improve detection of fluid behind the eardrum, crucial for diagnosing conditions like AOM. Early indications suggest it could assist doctors in making better decisions by providing more information during ear exams. This may lead to more accurate diagnoses and improved treatment plans for children with ear problems. ^{1 5 6 7 8}

Who Is on the Research Team?

Yi-Chun Liu, MD

Principal Investigator

Baylor College of Medicine

Tiffany Raynor, MD

Principal Investigator

Baylor College of Medicine

Shraddha Mukerji, MD

Principal Investigator

Baylor College of Medicine

Jennifer Yan, MD

Principal Investigator

Baylor College of Medicine

Sonal Saraiya, MD

Principal Investigator

Baylor College of Medicine

Mary E Williamson, MD

Principal Investigator

Baylor College of Medicine

Henri Traboulsi, MD

Principal Investigator

Baylor College of Medicine

Anna Messner, MD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 12 years old or younger.

I am getting my first set of ear tubes, possibly with other ear/nose procedures.

I need surgery for frequent ear infections, fluid in the ear, Eustachian tube problems, or hearing loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Algorithm Development

Ultrasound and visual otoscopic images are collected with an engineering prototype otoscope device for algorithm development.

1 year

Clinical Validation

The clinical validation phase is a double-blind study comparing ultrasound scores to surgical findings and lab analysis.

1 year and 6 months

Follow-up

Participants are monitored for safety and effectiveness after the main phases of the trial.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Advanced Ultrasound Otoscope

How Is the Trial Designed?

Group I: Clinical Validation Experimental Treatment 1 Intervention

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.

Group II: Algorithm Development Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

OtoNexus Medical Technologies, Inc.

Industry Sponsor

Trials

1

Recruited

300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06429709

Utility of Advanced Ultrasound Otoscope In The Diagnosis ... The objective of this study is to collect ultrasound signal information and visual otoscopic images with an engineering prototype device for children scheduled ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12582799/

Therapeutic outcomes of tympanostomy tube insertion for ... TTI is effective in resolving effusion in children, reducing OME severity and frequency, and improving children's quality of life. TTI ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2027278

Tympanostomy Tubes or Medical Management for ... The rate of episodes of acute otitis media during a 2-year period was not significantly lower with tympanostomy-tube placement than with medical management.

4. publications.aap.org publications.aap.org/pediatrics/article/133/2/296/30806/Surgical-Treatments-for-Otitis-Media-With-Effusion

Surgical Treatments for Otitis Media With Effusion Clinical outcomes: changes in middle ear fluid, episodes of ... Tube placement decreased the time with middle ear effusion by 32% in ...

5. ctv.veeva.com ctv.veeva.com/study/utility-of-advanced-ultrasound-otoscope-in-the-diagnosis-of-aom

Utility of Advanced Ultrasound Otoscope In The Diagnosis of ... The objective of this study is to collect ultrasound signal information and visual otoscopic images with an engineering prototype device for children ...

6. otonexus.com otonexus.com/

OtoNexus Medical Technologies OtoNexus Medical Technologies has developed an advanced ultrasound otoscope, engineered to accurately detect middle ear infections (Otitis Media).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3262273/

Ultrasonic imaging: safety considerations - PMC This review considers the existing laboratory and epidemiological evidence about the safety of diagnostic ultrasound and puts it in the context of current ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06429709/utility-of-advanced-ultrasound-otoscope-in-the-diagnosis-of-aom

Utility of Advanced Ultrasound Otoscope In The Diagnosis ... The objective of this study is to collect ultrasound signal information and visual otoscopic images with an engineering prototype device for children.