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Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM

NCT06429709 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

  • Otitis Media Recurrent
  • Middle Ear Infection
  • Ear Infection

Interventions

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

Sponsors & Collaborators

  • OtoNexus Medical Technologies, Inc.

    collaborator INDUSTRY

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Tiffany Raynor, MD · Baylor College of Medicine

  • Yi-Chun Liu, MD · Baylor College of Medicine

  • Shraddha Mukerji, MD · Baylor College of Medicine

  • Jennifer Yan, MD · Baylor College of Medicine

  • Sonal Saraiya, MD · Baylor College of Medicine

  • Mary E Williamson, MD · Baylor College of Medicine

  • Henri Traboulsi, MD · Baylor College of Medicine

  • Anna Messner, MD · Baylor College of Medicine

Eligibility

Min Age
0 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2026-05-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06429709 on ClinicalTrials.gov