Trials
Search / Trial NCT06429709

Utility of Advanced Ultrasound Otoscope In The Diagnosis of AOM

Launched by BAYLOR COLLEGE OF MEDICINE · May 23, 2024

Trial Information

Current as of February 19, 2025

Recruiting

Keywords

Otoscope Tympanogram Effusion Ultrasound

ClinConnect Summary

This clinical trial is looking at a new ultrasound device designed to help doctors better diagnose ear infections, specifically in children who need surgery to place pressure equalization (PE) tubes in their ears. The goal is to gather information from this special device, which combines ultrasound signals and images, to improve how we understand and identify conditions like recurrent ear infections and fluid buildup in the middle ear.

Children between the ages of newborn to 12 years who are having their first set of PE tubes placed due to frequent ear infections or related issues may be eligible to participate. However, children with certain ear problems, like a specific type of skin growth in the ear (cholesteatoma) or a hole in the eardrum, cannot join the study. If they participate, families can expect their child to use the new device along with standard medical care, helping researchers develop better diagnostic tools for ear infections in the future.

Gender

ALL

Eligibility criteria

  • 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.

Trial Officials

Tiffany Raynor, MD

Study Chair

Baylor College of Medicine

Yi-Chun Liu, MD

Principal Investigator

Baylor College of Medicine

Shraddha Mukerji, MD

Study Chair

Baylor College of Medicine

Jennifer Yan, MD

Study Chair

Baylor College of Medicine

Sonal Saraiya, MD

Study Chair

Baylor College of Medicine

Mary E Williamson, MD

Study Chair

Baylor College of Medicine

Henri Traboulsi, MD

Study Chair

Baylor College of Medicine

Anna Messner, MD

Study Chair

Baylor College of Medicine

About Baylor College Of Medicine

Baylor College of Medicine is a leading academic institution dedicated to advancing health through innovative research, education, and clinical care. Located in Houston, Texas, it is renowned for its commitment to excellence in medical education and translational research, fostering collaborations that bridge laboratory discoveries with clinical application. As a clinical trial sponsor, Baylor College of Medicine leverages its robust infrastructure, interdisciplinary expertise, and access to diverse patient populations to conduct cutting-edge clinical studies aimed at improving patient outcomes and enhancing therapeutic approaches across a wide range of medical conditions.

Locations

Houston, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0