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NCT07222293 · ClinicalTrials.gov registry record
Assessment of AI Program 'DRISTi' as a Screening Tool
A clinical trial of Diabetic Retinopathy (DR), sponsored by Artelus AI.
- Recruiting
- Registry status
- 900
- Enrollment target
- 2
- Study locations
NCT07222293: Recruiting study of Diabetic Retinopathy (DR), sponsored by Artelus AI.
NCT07222293 is a study of Diabetic Retinopathy (DR) that is actively recruiting participants, run by Artelus AI. The registered enrollment target is 900 participants, above the 330-participant average among 5 other Diabetic Retinopathy (DR) trials with a reported enrollment target (173% higher). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07222293, a study of Diabetic Retinopathy (DR), is actively recruiting participants, sponsored by Artelus AI.
- RECRUITING
- Registry status
- 900 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
AI generated image grades are directly compared to a Human generated image grade
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Fundus Image Grading
Study Locations (2)
North Carolina
- New Century Ophthalmology - Oxford - Oxford
- New Century Ophthalmology - Raleigh - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 900 participants |
| Start Date | 2025-11-23 |
| Est. Completion | 2026-03 |
What NCT07222293 shows while recruiting
NCT07222293 is an observational study that tracks outcomes without assigning an intervention. The registered 900 participants enrollment target is mid-sized for trials with a published cap, above the 330-participant average among 5 other Diabetic Retinopathy (DR) trials with a reported enrollment target (173% higher).
The record links to 1 condition, with Diabetic Retinopathy (DR) appearing as the primary indexed condition, and to 1 intervention - of which Fundus Image Grading is the first listed.
NCT07222293 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT07222293 about?
NCT07222293 is a clinical study titled "Assessment of AI Program 'DRISTi' as a Screening Tool". 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 ...
What is the current status of trial NCT07222293?
This trial is currently recruiting. The enrollment target is 900 participants. The study started on 2025-11-23. Estimated completion is 2026-03.
What conditions does trial NCT07222293 study?
This clinical trial studies the following conditions: Diabetic Retinopathy (DR).
What interventions are being tested in trial NCT07222293?
The interventions under investigation include: Fundus Image Grading (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07222293?
This trial is sponsored by Artelus AI, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07222293 being conducted?
This trial has 2 study locations across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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