Active — Not RecruitingNot Applicable

Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM

United States300 participantsStarted 2021-09-01

Plain-language 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.

Who can participate

Age range0 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Device Performance

Timeframe: 2 years and 6 months

Trial details

NCT IDNCT06429709

SponsorBaylor College of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-31

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