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Clinical Evaluation of the OtoSight

NCT03890107 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2023-05-22

No results posted yet for this study

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.

Conditions

  • Otitis Media

Interventions

DEVICE

OtoSight Middle Ear Scope

OtoSight imaging using a near-infrared laser

Sponsors & Collaborators

  • Carle Foundation Hospital

    collaborator OTHER

  • Children's National Research Institute

    collaborator OTHER

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

    collaborator NIH

  • PhotoniCare, Inc.

    lead INDUSTRY

Principal Investigators

  • Ryan Shelton, PhD · PhotoniCare, Inc.

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2021-04-30
Completion
2022-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03890107 on ClinicalTrials.gov