Pivotal Trial for an Automated AI-based System for Detection of Diabetic Retinopathy
ConditionDiabetic Retinopathy (DR)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorDigital Diagnostics, Inc.
About this trial
Assessment of an autonomous AI system for diabetic retinopathy detection in adults with diabetes using retinal imaging.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
22 years of age or older
Diagnosis of DM
Ability to understand and willing to sign a written ICF
Disqualifiers
None
Trial population
Diabetic adult population with no previous diagnosis of DR
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
SaMD intended for the detection of diabetic retinopathy in adults with diabetes.
DeviceNo significant difference to other SaMDs for the detection of DR that are commercialized.
An AI/ML-based Software as a Medical Device (SaMD) for the automated detection of diabetic retinopathy in adults with diabetes.
DeviceSaMD to detect diabetic retinopathy
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Single arm, non-randomized cohort2 interventions
Trial outcomes
Primary outcomes
1
Evaluation of the safety and efficacy of an AI-based SaMD with a fundus camera for the detection of Diabetic Retinopathy
Time frame
1-yearSponsors and contacts
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Source ClinicalTrials.gov