Trials / Completed
CompletedNCT04905459
ARDA Software for the Detection of mtmDR
A Multicenter Study to Evaluate the Performance of Automated Retinal Disease Assessment Software for the Detection of More Than Mild Diabetic Retinopathy
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,012 (actual)
- Sponsor
- Verily Life Sciences LLC · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | ARDA software application | Subject images will be sent to the investigational ARDA software |
Timeline
- Start date
- 2021-09-30
- Primary completion
- 2022-05-23
- Completion
- 2022-05-23
- First posted
- 2021-05-27
- Last updated
- 2022-06-06
Locations
13 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04905459. Inclusion in this directory is not an endorsement.