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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: Completed NA study, sponsored by Siloam Vision.
NCT06517836 is a NA study that has completed, run by Siloam Vision. The registered enrollment target is 1,284 participants, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
sensitivity and specificity of the I-ROP DL system for more than mild ROP and treatment requiring (type 1) ROP
Interventions
- DEVICE iROP DL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,284 participants |
| Start Date | 2024-10-20 |
| Est. Completion | 2025-03-01 |
| Phase | NA |
What the finished NCT06517836 record still lists
NCT06517836 is an interventional study that assigns participants to a tested intervention. Its 1,284 participants enrollment target places it among the larger protocols in the corpus, roughly in line with the 1,404-participant average among 58,714 other NA trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which iROP DL is the first listed.
NCT06517836 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06517836's enrollment target sits among peer trials
1,284 78th of 2000 higher than 1,923 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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