Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-21 @ 6:45 PM
Study NCT ID:
NCT06467903
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners, Using SW as Medical Device
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'specific screening exhamination'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-20', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-20', 'lastUpdatePostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity', 'timeFrame': '3 months', 'description': 'The sensitivity and specificity will be calculated using the evaluation of independent masked expert (ophthalmologist) as gold standard.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'A prospective, comparative multicenter evaluation conducted to capture patients with diabetic retinopathy in general practitioners, using AI medical device', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women aged ≥ 40 years\n* Signed informed consent\n* Confirmed type 1 or 2 diabetes mellitus\n\nExclusion Criteria:\n\n* Ocular findings that do not allow retinal photography (significant nystagmus, corneal leukoma, dense cataract, hemophthalmus, etc.)\n* 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\n* Patients with restrictions on personal freedom by administrative or legal order"}, 'identificationModule': {'nctId': 'NCT06467903', 'acronym': 'Retina', 'briefTitle': 'Evaluation Conducted to Capture Patients With Diabetic Retinopathy in General Practitioners, Using SW as Medical Device', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bonmedix Holding a.s.'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': 'Retina_01_2024'}, 'secondaryIdInfos': [{'id': 'sukls117945/2024', 'type': 'OTHER', 'domain': 'SUKL'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'one arm - 1000 patients, DR screening', 'description': "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) .", 'interventionNames': ["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': [{'name': "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': 'DEVICE', 'description': "second AI medical device to evaluate the retinal image of the patient's eye. two AI as MD will be evaluating the retinal image", 'armGroupLabels': ['one arm - 1000 patients, DR screening']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Příbram', 'state': 'Or', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Sedivy, MD', 'role': 'CONTACT'}], 'facility': 'Jakub Sedivy', 'geoPoint': {'lat': 49.68988, 'lon': 14.01043}}], 'centralContacts': [{'name': 'Pavlina Kasparova Walter, MBA', 'role': 'CONTACT', 'email': 'pavlinakasparova@gmail.com', 'phone': '776661512', 'phoneExt': '00420'}, {'name': 'Jiří Tomšej, ING', 'role': 'CONTACT', 'email': 'tomsej@viderai.com', 'phone': '777108402', 'phoneExt': '00420'}], 'overallOfficials': [{'name': 'Petr Šonka, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'GP'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bonmedix Holding a.s.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}