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Pivotal Trial of Automated Artificial Intelligence (AI) Based System for Early Diagnosis of Diabetic Retinopathy
NCT07151001 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07151001
The ClinicalTrials.gov registry entry for NCT07151001 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 922 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is iHealthScreen, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07151001 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07151001?
The interventions under investigation include: No intervention (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07151001?
This trial is sponsored by iHealthScreen, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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