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NCT02383420 · ClinicalTrials.gov registry record · NA
Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors
A NA study, sponsored by Carestream Health.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT02383420: Completed NA study, sponsored by Carestream Health.
NCT02383420 is a NA study that has completed, run by Carestream Health. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02383420, a NA study, has completed, sponsored by Carestream Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study Summary
The purpose of this clinical study is to evaluate the imaging performance of the Carestream PRO 3543 Detector and Carestream PRO 3543C Detector (referred to as the "investigational devices") as compared to the currently marketed Carestream DRX-1 Detector (referred to as the "predicate device"). Both detectors are flat panel digital imaging devices. The results of this study will be included in a Traditional 510(k) FDA Submission to obtain clearance to market the new detectors in the US. The study was designed in accordance with the FDA Guidance titled "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices", issued on August 6, 1999.
Primary Outcome
1-Non-diagnostic Unacceptable for diagnostic purposes. Little or no clinically usable diagnostic information (e.g., gross underexposure, system failure or extensive motion artifact). Almost all such imaging should be repeated. 2-Limited Acceptable, with some technical defect (motion artifact, body habitus/poor x-ray penetration, or patient positioning may limit visualization of some body-regions but still adequate for diagnostic purposes). Not as much diagnostic information as is typical for an
Interventions
- RADIATION Radiation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-04 |
| Phase | NA |
What the finished NCT02383420 record still lists
NCT02383420 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Radiation is the first listed.
NCT02383420 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02383420 about?
NCT02383420 is a clinical study titled "Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors". The purpose of this clinical study is to evaluate the imaging performance of the Carestream PRO 3543 Detector and Carestream PRO 3543C Detector (referred to as the "investigational devices") as compared to the currently marketed Carestream DRX-1 Detector (referred to as the "predicate device"). Both...
What is the current status of trial NCT02383420?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2015-02. Estimated completion is 2015-04.
What interventions are being tested in trial NCT02383420?
The interventions under investigation include: Radiation (RADIATION).
Who is sponsoring clinical trial NCT02383420?
This trial is sponsored by Carestream Health, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02383420's enrollment target sits among peer trials
23 1755th of 2000 higher than 245 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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