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NCT02337959 · ClinicalTrials.gov registry record · NA

Clinical Evaluation of DRX Plus 3543 and DRX Plus 3543C Digital Detectors

A NA study, sponsored by Carestream Health.

Completed
Registry status
NA
Development phase
27
Enrollment target

NCT02337959 is a NA study that has completed, run by Carestream Health. The registered enrollment target is 27 participants.

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The verdict

NCT02337959, a NA study, has completed, sponsored by Carestream Health.

COMPLETED
Registry status
NA
Development phase
27 participants
Enrollment target

Study Summary

The purpose of this clinical study is to evaluate the imaging performance of the DRX Plus 3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) as compared to the currently marketed Carestream DRX-1 Detector. 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.

Interventions

  • RADIATION Radiation

Trial Details

FieldValue
Enrollment Target 27 participants
Start Date 2015-01
Est. Completion 2015-03
Phase NA

Sponsor

Carestream Health

4 total trials

What the Registry Record Tells You About NCT02337959

The ClinicalTrials.gov registry entry for NCT02337959 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carestream Health, which has 4 total studies on file at ClinicalTrials.gov.

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

NCT02337959 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02337959 about?

NCT02337959 is a clinical study titled "Clinical Evaluation of DRX Plus 3543 and DRX Plus 3543C Digital Detectors". The purpose of this clinical study is to evaluate the imaging performance of the DRX Plus 3543 and DRX Plus 3543C Detectors (flat panel digital imaging devices) as compared to the currently marketed Carestream DRX-1 Detector. The results of this study will be included in a Traditional 510(k) FDA Sub...

What is the current status of trial NCT02337959?

This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2015-01. Estimated completion is 2015-03.

What interventions are being tested in trial NCT02337959?

The interventions under investigation include: Radiation (RADIATION).

Who is sponsoring clinical trial NCT02337959?

This trial is sponsored by Carestream Health, which has 4 total clinical trials registered on ClinicalTrials.gov.

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

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.