Diabetes MellitusRetinaNCT06467903
Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners, Using SW as Medical Device
A study testing 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) . in people with Diabetes Mellitus, run by Bonmedix Holding a.s. at 1 site in Czechia.
Trial summary
A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using AI medical device Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- 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) .
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Jun 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged ≥ 40 years
- Signed informed consent
- Confirmed type 1 or 2 diabetes mellitus
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using AI medical device
Read the 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
- Being tested
- 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) .
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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) . Receives: 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) . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity
The sensitivity and specificity will be calculated using the evaluation of independent masked expert (ophthalmologist) as gold standard.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start7 Jun 2024
- Primary completion28 Oct 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- specific screening exhamination
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bonmedix Holding a.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Petr Šonka, MD, Principal investigator, GP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467903
- Sponsor's protocol ID
- Retina_01_2024
- Other IDs
- sukls117945/2024
- Acronym
- Retina
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06467903
- Acronym / sponsor ID
- Retina / Retina_01_2024
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Bonmedix Holding a.s.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 28 Oct 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- specific screening exhamination
| Arm | Type | Receives |
|---|---|---|
| one arm - 1000 patients, DR screening | Experimental | 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) .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) . |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women aged ≥ 40 years
- Signed informed consent
- Confirmed type 1 or 2 diabetes mellitus
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | one arm - 1000 patients, DR screening |
Primary outcome
Sensitivity and specificity
Time frame: 3 months
The sensitivity and specificity will be calculated using the evaluation of independent masked expert (ophthalmologist) as gold standard.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Šonka, MD principal investigator
GP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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) . in people with Diabetes Mellitus, run by Bonmedix Holding a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pavlina Kasparova Walter, MBA (776661512 ext. 00420, pavlinakasparova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.