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Clinical Validation for Otitis Media

N/A
Recruiting
Led By Yi-Chun Liu, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

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.

Eligible Conditions
  • Otitis Media
  • Ear Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Device Performance
Secondary outcome measures
Device Usability

Trial Design

2Treatment groups
Experimental Treatment
Group I: Clinical ValidationExperimental Treatment1 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 DevelopmentExperimental Treatment1 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

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Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,006 Previous Clinical Trials
6,003,008 Total Patients Enrolled
2 Trials studying Otitis Media
336 Patients Enrolled for Otitis Media
OtoNexus Medical Technologies, Inc.Industry Sponsor
Sonal Saraiya, MDStudy ChairBaylor College of Medicine
~75 spots leftby Sep 2025
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