Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM

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

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Mary E Williamson, MD

Principal Investigator

Baylor College of Medicine

Tiffany Raynor, MD

Principal Investigator

Baylor College of Medicine

Yi-Chun Liu, MD

Principal Investigator

Baylor College of Medicine

Shraddha Mukerji, 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

Jennifer Yan, MD

Principal Investigator

Baylor College of Medicine

Sonal Saraiya, 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?

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+