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

NCT ID: NCT06467903

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-07
• Study Completion Date: 2024-12-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

one arm - 1000 patients, DR screening

SW as medical devices(investigational device) to evaluate the retinal image of the patient's eye (to identify if the patient has DR or if the patient is healthy) .

Group Type: EXPERIMENTAL

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) .

Intervention Type: DEVICE

second AI medical device to evaluate the retinal image of the patient's eye. two AI as MD will be evaluating the retinal image

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Men and women aged ≥ 40 years
• Signed informed consent
• Confirmed type 1 or 2 diabetes mellitus

Exclusion Criteria

• Ocular findings that do not allow retinal photography (significant nystagmus, corneal leukoma, dense cataract, hemophthalmus, etc.)
• Patient has a condition or is in a situation that, in the opinion of the investigator, may bias the results of the study, may significantly interfere with the patient's participation in the investigation, or may result in unproducible photographs of a dilated ocular fundus
• Patients with restrictions on personal freedom by administrative or legal order

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bonmedix Holding a.s.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Petr Šonka, MD

Role: PRINCIPAL_INVESTIGATOR

GP

Locations

Jakub Sedivy

Příbram, Or, Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Pavlina Kasparova Walter, MBA

Role: CONTACT

pavlinakasparova@gmail.com

776661512 ext. 00420

Jiří Tomšej, ING

Role: CONTACT

tomsej@viderai.com

777108402 ext. 00420

Facility Contacts

Sedivy, MD

Role: primary

Other Identifiers

sukls117945/2024

Identifier Type: OTHER

Identifier Source: secondary_id

Retina_01_2024

Identifier Type: -

Identifier Source: org_study_id