Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT07222293
Status:
RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of AI Program 'DRISTi' as a Screening Tool
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-10-25', 'studyFirstSubmitQcDate': '2025-10-27', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of AI Grade', 'timeFrame': 'From time of arrival to completion of diagnostic tests, up to 8 hours', 'description': 'AI generated image grades are directly compared to a Human generated image grade'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Artificial Intelligence', 'Ophthalmic Device', 'AI', 'Diabetic Retinopathy', 'Diabetes', 'DR', 'Screening', 'Online/Offline', 'Fundus Camera'], 'conditions': ['Diabetic Retinopathy (DR)']}, 'descriptionModule': {'briefSummary': 'A study will be conducted to demonstrate that DRISTi will correctly diagnose Diabetic Retinopathy (e.g., mtmDR, PDR, DME) in eyes of patients with diabetes. Participants who have been diagnosed with diabetes mellitus and meet the other inclusion/exclusion criteria will be invited to participate and will consent to have ophthalmic images taken. These images will be analyzed by DRISTi AI software and evaluated by an ophthalmic reading center. The results will be compared, and a statistical analysis will be completed to ensure statistical significance in the outcomes thus proving DRISTi is an effective DR diagnosis tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be referred from primary care clinics and ophthalmology clinics in North Carolina.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ability to sign and date the informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Age (≥)21 years of age or older\n4. Diagnosed with diabetes mellitus as per criteria established by the World Health Organization (WHO) or the American Diabetes Association (ADA)\n\n 1. Hemoglobin A1c (HbA1c) ≥ 6.5%\n 2. Fasting Plasma Glucose (FPG) ≥ 126 mg/dL (7.0 mmol/L)\n 3. Symptoms of hyperglycemia or hyperglycemic crisis with a random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L)\n\nExclusion Criteria:\n\n1. Persistent visual impairment in one or both eyes;\n2. History of macular edema or retinal vascular (vein or artery) occlusion;\n3. History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;\n4. Subject is contraindicated for fundus photography (for example, has light sensitivity);\n5. Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;\n6. Subject is currently enrolled in an interventional study of an investigational device or drug for the same condition; or\n7. Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or may result in ungradable clinical reference standard photographs\n8. Subject falls into one of the below categories:\n\n * Adults unable to consent (individuals w/ impaired decision-making capacity)\n * Individuals who are not yet adults (infants, children, teenagers)\n * Pregnant women\n * Prisoners"}, 'identificationModule': {'nctId': 'NCT07222293', 'briefTitle': "Assessment of AI Program 'DRISTi' as a Screening Tool", 'organization': {'class': 'INDUSTRY', 'fullName': 'Artelus AI'}, 'officialTitle': "Assessment of 'DRISTi' as an Automated Diabetic Retinopathy Screening Tool in Diabetic Populations", 'orgStudyIdInfo': {'id': '25-02-199'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fundus Image Grading', 'type': 'DIAGNOSTIC_TEST', 'description': 'The image is graded by a fully automated AI device'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27565', 'city': 'Oxford', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeanne Champion, Site Coordinator Oxford', 'role': 'CONTACT', 'email': 'Jeanne@ncophth.com', 'phone': '9192347003'}, {'name': 'Chaitan Walia, Study Coordinator, BA', 'role': 'CONTACT', 'email': 'cpwalia7@gmail.com', 'phone': '3129738490'}, {'name': 'Vinod Jindal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New Century Ophthalmology - Oxford', 'geoPoint': {'lat': 36.3107, 'lon': -78.59083}}, {'zip': '27617', 'city': 'Raleigh', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adriana Valencia, Site Coordinator Raleigh', 'role': 'CONTACT', 'email': 'Adriana@ncophth.com', 'phone': '9192347406'}, {'name': 'Chaitan Walia, Study Coordinator, BA', 'role': 'CONTACT', 'email': 'cpwalia7@gmail.com', 'phone': '3129738490'}, {'name': 'Sumeet Jindal, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Vinod Jindal, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'New Century Ophthalmology - Raleigh', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}], 'centralContacts': [{'name': 'Jeanne Champion, Primary Site Coordinator Oxford', 'role': 'CONTACT', 'email': 'Jeanne@ncophth.com', 'phone': '9192347003'}, {'name': 'Adriana Valencia, Site Coordinator Raleigh', 'role': 'CONTACT', 'email': 'Adriana@ncophth.com', 'phone': '9192347406'}], 'overallOfficials': [{'name': 'Vinod Jindal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New Century Ophthalmology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'resource constraints'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Artelus AI', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}