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NCT06517836 · ClinicalTrials.gov registry record · NA

Automated Screening Device to Detect MTMROP

A NA study, sponsored by Siloam Vision.

Completed
Registry status
NA
Development phase
1,284
Enrollment target

NCT06517836 is a NA study that has completed, run by Siloam Vision. The registered enrollment target is 1,284 participants.

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The verdict

NCT06517836, a NA study, has completed, sponsored by Siloam Vision.

COMPLETED
Registry status
NA
Development phase
1,284 participants
Enrollment target

Study Summary

The purpose of the study is to evaluate the i-ROP DL system for autonomous ROP screening. To demonstrate the sensitivity and specificity of the i-ROP DL system on images obtained by healthcare providers in the neonatal intensive care unit (NICU) setting to detect more than mild ROP (MTMROP), defined as type 2 or worse (as defined by the Early Treatment for ROP \[ETROP\] study), or pre-plus, compared to an image-based reference standard diagnosis (RSD). This study will utilize a large multicenter dataset of images obtained as part of the Multicenter Telemedicine Approaches to Evaluating Acute-phase ROP (e-ROP) Study, a National Institute of Health multicenter study.

Interventions

  • DEVICE iROP DL

Trial Details

FieldValue
Enrollment Target 1,284 participants
Start Date 2024-10-20
Est. Completion 2025-03-01
Phase NA

Sponsor

Siloam Vision

2 total trials

What the Registry Record Tells You About NCT06517836

The ClinicalTrials.gov registry entry for NCT06517836 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 1,284 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Siloam Vision, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which iROP DL is the first listed.

NCT06517836 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT06517836 about?

NCT06517836 is a clinical study titled "Automated Screening Device to Detect MTMROP". The purpose of the study is to evaluate the i-ROP DL system for autonomous ROP screening. To demonstrate the sensitivity and specificity of the i-ROP DL system on images obtained by healthcare providers in the neonatal intensive care unit (NICU) setting to detect more than mild ROP (MTMROP), defined...

What is the current status of trial NCT06517836?

This trial is currently completed. It is a NA study. The enrollment target is 1,284 participants. The study started on 2024-10-20. Estimated completion is 2025-03-01.

What interventions are being tested in trial NCT06517836?

The interventions under investigation include: iROP DL (DEVICE).

Who is sponsoring clinical trial NCT06517836?

This trial is sponsored by Siloam Vision, which has 2 total clinical trials registered on ClinicalTrials.gov.

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

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