Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

Sensitivity and specificity
The sensitivity and specificity will be calculated using the evaluation of independent masked expert (ophthalmologist) as gold standard.
3 months

Study Arms (1)

one arm - 1000 patients, DR screening

EXPERIMENTAL

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) .

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) .

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) .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

one arm - 1000 patients, DR screening

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Men and women aged ≥ 40 years
Signed informed consent

Sponsors & Collaborators

Bonmedix Holding a.s.
Industrylead

Study Sites (1)

Jakub Sedivy

Příbram, Or, Czechia

RECRUITING

Sedivy, MDCONTACT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Petr Šonka, MD
GP
PRINCIPAL INVESTIGATOR

Central Study Contacts

Pavlina Kasparova Walter, MBA

CONTACT

776661512 pavlinakasparova@gmail.com

Jiří Tomšej, ING

CONTACT

777108402

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: SCREENING
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 10, 2024

First Posted

June 21, 2024

Study Start

June 7, 2024

Actual (reported)

Primary Completion

October 28, 2024

Estimated (date passed)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

one arm - 1000 patients, DR screening

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

one arm - 1000 patients, DR screening

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations