NCT06467903

Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners, Using SW as Medical Device

A Prospective, Comparative Multicenter Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners, Using the SW as Medical Device and the SW as MD Comparator, When Evaluating the Patient's Retinal Image

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Bonmedix Holding a.s. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using AI medical device

Detailed description

A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using the SWaMD medical device and the SWaMD comparator, when evaluating the patients retinal image

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	SW as medical devices(comperator) to evaluate the retinal image of the patient's eye (to identify if the patient has DR or if the patient is healthy) .	second AI medical device to evaluate the retinal image of the patient's eye. two AI as MD will be evaluating the retinal image

Timeline

• Start date: 2024-06-07
• Primary completion: 2024-10-28
• Completion: 2024-12-15
• First posted: 2024-06-21
• Last updated: 2024-06-21

Locations

1 site across 1 country: Czechia