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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 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.

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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.

Conditions Studied

Diabetes Diabetic Retinopathy

Interventions

  • DEVICE No intervention

Study Locations (1)

New York

  • iHealthScreen Inc. - Richmond Hill

Trial Details

FieldValue
Enrollment Target 922 participants
Start Date 2025-01-01
Est. Completion 2027-07-31

Sponsor

iHealthScreen

2 total trials

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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, categorized as an unspecified phase. The registered enrollment target is 922 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,026-participant average among 338 other Diabetes trials with a reported enrollment target (70% lower). The listed sponsor is iHealthScreen, which has 2 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.