CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
Radiationradiation
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02337959
NCT02337959N/ACompleted
CompareCT.gov

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

Carestream Health, Inc.·interventional·Posted Jan 14, 2015·Updated Apr 18, 2016

In Brief

A clinical study evaluating Radiation for Healthy. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 14, 2015
Enrollment StartJan 1, 2015
Primary CompletionJan 1, 2015
Study CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 0 daysPosted 11.5 years ago

Interventions

Radiationradiation

Live subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector. Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detectors.