ARDA Software for the Detection of mtmDR
NCT04905459 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1012
Last updated 2022-06-06
Summary
This is a multicenter, observational study with primary endpoints to determine the sensitivity and specificity of two investigational software devices that detect the presence of more than mild diabetic retinopathy (mtmDR) in healthcare settings.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
ARDA software application
Subject images will be sent to the investigational ARDA software
Sponsors & Collaborators
-
Google LLC.
collaborator INDUSTRY -
Optos, PLC
collaborator INDUSTRY -
Nikon Corporation
collaborator UNKNOWN -
The Emmes Company, LLC
collaborator INDUSTRY -
Verily Life Sciences LLC
lead INDUSTRY
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-30
- Primary Completion
- 2022-05-23
- Completion
- 2022-05-23
- FDA Device
- Yes
Countries
- United States
Study Locations
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