Clinical Evaluation of the OtoSight

PhotoniCare

Status: Completed

Conditions: Otitis Media

Treatments: Device: OtoSight Middle Ear Scope

Study type: Observational

Funder types: Other; Industry; NIH

Identifiers

NCT03890107

R44DC014599 (U.S. NIH Grant/Contract)

000001

Details and patient eligibility

About

The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of OtoSight imaging will not affect patient standard of care.

Enrollment: 110 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children (17 years old or younger) scheduled for tympanostomy tube placement

Exclusion criteria

• Otoscopy contra-indicated or not possible per attending physician's decision

Trial design

110 participants in 1 patient group

Pediatric tympanostomy tube patients

Description:

Patients diagnosed with otitis media and scheduled for tympanostomy tube placement will be imaged with the OtoSight

Treatment:

Device: OtoSight Middle Ear Scope