Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM

NCT06429709 | Active Not Recruiting

• 1 other identifier: H-50018
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Otoscope; Tympanogram; Effusion; Ultrasound

Outcome Measures

Primary Outcomes (1)

• Device Performance

  Correlations of device measurements and ultrasound data for Noninfected fluid and Bacterial Fluid to the gold standard of surgeon's findings at myringotomy.

  2 years and 6 months

Secondary Outcomes (1)

• Device Usability

  1 year

Study Arms (2)

Algorithm Development

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

Device: Advanced Ultrasound Otoscope

Clinical Validation

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.

Device: Advanced Ultrasound Otoscope

Interventions

Advanced Ultrasound Otoscope DEVICE

The Advanced Ultrasound Otoscope is a tool for visualization of the human tympanic membrane and detection of middle ear effusion type

Algorithm Development; Clinical Validation

Eligibility Criteria

• Age: 0 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The investigators will be recruiting patients between 0 months and 12 years of age who meet the listed inclusion criteria and do not meet any of the listed exclusion criteria. The investigators are not selecting patients based on race/ethnicity or gender/sex. Parents must be fluent in either English or Spanish.

You may qualify if:

• 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.

You may not qualify if:

• Cholesteatoma, tympanic membrane perforation, myringitis
• History of PE tube placement or PE tubes currently in place.

Sponsors & Collaborators

• Baylor College of Medicine: lead
• OtoNexus Medical Technologies, Inc.: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Otitis Media; Otitis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Tiffany Raynor, MD

  Baylor College of Medicine

  STUDY CHAIR

• Yi-Chun Liu, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Shraddha Mukerji, MD

  Baylor College of Medicine

  STUDY CHAIR

• Jennifer Yan, MD

  Baylor College of Medicine

  STUDY CHAIR

• Sonal Saraiya, MD

  Baylor College of Medicine

  STUDY CHAIR

• Mary E Williamson, MD

  Baylor College of Medicine

  STUDY CHAIR

• Henri Traboulsi, MD

  Baylor College of Medicine

  STUDY CHAIR

• Anna Messner, MD

  Baylor College of Medicine

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: May 28, 2024
• Study Start: September 1, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)