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NCT07151001 · ClinicalTrials.gov registry record
Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy
A clinical trial of Diabetes and Diabetic Retinopathy, sponsored by iHealthScreen.
- Recruiting
- Registry status
- 922
- Enrollment target
- 1
- Study location
NCT07151001: Recruiting study of Diabetes and Diabetic Retinopathy, sponsored by iHealthScreen.
NCT07151001 is a study of Diabetes and Diabetic Retinopathy that is actively recruiting participants, run by iHealthScreen. The registered enrollment target is 922 participants, below the 3,026-participant average among 338 other Diabetes trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07151001, a study of Diabetes and Diabetic Retinopathy, is actively recruiting participants, sponsored by iHealthScreen.
- RECRUITING
- Registry status
- 922 participants
- Enrollment target
- 1
- Study location
Study Summary
In this pivotal trial, we aim to perform a prospective study to find the efficacy of iPredict-DR, an artificial intelligence (AI) based software tool on early diagnosis of Diabetic Retinopathy (DR) in the primary care and endocrinology clinics. DR is one of the leading causes of blindness in the United States and other developed countries. Every individual with diabetes is at risk of DR. It does not show any symptoms until the disease is progressed to advanced stages. If the disease is caught at an early stage, it can be prevented, managed, or treated effectively. Currently, screening for DR is done by the Ophthalmologists, which is limited to areas with limited availability. This is also time-consuming and expensive. All of these can be complemented by automated screening and set up the screening in the primary care clinics.
Primary Outcome
Sensitivity and specificity of identification of referable and non-referable DR for early diagnosis of DR using the iPredict-DR's AI-based DR screening software utilizing color fundus imaging. iPredict-DR can detect non-referable DR (normal retina or mild DR) and referable DR (moderate or severe DR including moderate non-proliferative, proliferative DR and diabetic macular edema) at a similar level of expert ophthalmologists. For this, the healthcare workers will be taking the disc and macula ce
Conditions Studied
Interventions
- DEVICE No intervention
Study Locations (1)
New York
- iHealthScreen Inc. - Richmond Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 922 participants |
| Start Date | 2025-01-01 |
| Est. Completion | 2027-07-31 |
What NCT07151001 shows while recruiting
NCT07151001 is an observational study that tracks outcomes without assigning an intervention. The registered 922 participants enrollment target is mid-sized for trials with a published cap, below the 3,026-participant average among 338 other Diabetes trials with a reported enrollment target (70% lower).
The record links to 2 conditions, with Diabetes appearing as the primary indexed condition, and to 1 intervention - of which No intervention is the first listed.
NCT07151001 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT07151001 about?
NCT07151001 is a clinical study titled "Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy". In this pivotal trial, we aim to perform a prospective study to find the efficacy of iPredict-DR, an artificial intelligence (AI) based software tool on early diagnosis of Diabetic Retinopathy (DR) in the primary care and endocrinology clinics. DR is one of the leading causes of blindness in the Uni...
What is the current status of trial NCT07151001?
This trial is currently recruiting. The enrollment target is 922 participants. The study started on 2025-01-01. Estimated completion is 2027-07-31.
What conditions does trial NCT07151001 study?
This clinical trial studies the following conditions: Diabetes, Diabetic Retinopathy.
What interventions are being tested in trial NCT07151001?
The interventions under investigation include: No intervention (DEVICE).
Who is sponsoring clinical trial NCT07151001?
This trial is sponsored by iHealthScreen, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07151001 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07151001's enrollment target sits among peer trials
922 47th of 338 higher than 292 of 338 other Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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