A Study To Evaluate The Otonexus Ultrasound Otoscope

Overview

About this study

The purpose of this study is to evaluate usability of the OtoNexus device when used in pediatric and adult patients in a clinical setting to detect middle ear effusion, and to determine if it is viral, bacterial, or mucoid.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Pediatric patients age to 17 years old, inclusive.
  • Parental or LAR informed consent for patients ages 6 years and younger.
  • Parental or LAR informed consent and subject assent for subjects ages to 17.
  • Adult patients ages 18 to 70, inclusive.
  • Informed consent for subjects ages 18-70.

Exclusion Criteria:

  • Any condition that, in the opinion of the Investigator, would make the subject inappropriate for the evaluation.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Shelagh Cofer, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions