Clinical Evaluation of the OtoSight

Clinical Evaluation of a New Middle Ear Diagnostic to Support FDA Regulatory Clearance

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03890107

Enrollment

110

Registered

2019-03-26

Start date

2019-04-15

Completion date

2022-04-30

Last updated

2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media

Keywords

Ear Infection, Ear tubes, Myringotomy, Otitis Media, Tympanostomy

Brief summary

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.

Interventions

DEVICEOtoSight Middle Ear Scope

OtoSight imaging using a near-infrared laser

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 17 Years

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

Design outcomes

Primary

Measure	Time frame	Description
OtoSight imaging exam	1-5 minutes	Optical coherence tomography imaging to evaluate the middle ear.

Secondary

Measure	Time frame	Description
Adverse events	Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer)	Rate of adverse events

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026