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NCT01318772 · ClinicalTrials.gov registry record
Clinical Image Evaluation for the DREX-KL80 Imaging System
A clinical trial of Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation., sponsored by Toshiba America Medical Systems.
- Completed
- Registry status
- 42
- Enrollment target
- 1
- Study location
NCT01318772 is a study of Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation. that has completed, run by Toshiba America Medical Systems. The registered enrollment target is 42 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01318772, a study of Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation., has completed, sponsored by Toshiba America Medical Systems.
- COMPLETED
- Registry status
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to acquire the clinical data required by the United States Food and Drug Administration (USFDA) for 510(k) submission, for approval of a new high resolution imaging system for fluoroscopy/radiography. It is expected that the new KALARE (DREX-KL80)high resolution imaging system will meet the design specifications. A minimum of 30 cases will be submitted for evaluation of claims for intended clinical applications.
Conditions Studied
Interventions
- DEVICE Radiography and Fluoroscopy Imaging System
Study Locations (1)
Nevada
- SDMI - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2010-12 |
| Est. Completion | 2011-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01318772
The ClinicalTrials.gov registry entry for NCT01318772 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Toshiba America Medical Systems, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation. appearing as the primary indexed condition, and to 1 intervention - of which Radiography and Fluoroscopy Imaging System is the first listed.
NCT01318772 reports 1 study location spanning 1 distinct geographic area - top geographies include Nevada.
Frequently Asked Questions
What is clinical trial NCT01318772 about?
NCT01318772 is a clinical study titled "Clinical Image Evaluation for the DREX-KL80 Imaging System". The purpose of this study is to acquire the clinical data required by the United States Food and Drug Administration (USFDA) for 510(k) submission, for approval of a new high resolution imaging system for fluoroscopy/radiography. It is expected that the new KALARE (DREX-KL80)high resolution imaging ...
What is the current status of trial NCT01318772?
This trial is currently completed. The enrollment target is 42 participants. The study started on 2010-12. Estimated completion is 2011-01.
What conditions does trial NCT01318772 study?
This clinical trial studies the following conditions: Obtain Diagnostic Images With the New Digital Camera and Image Processor for Evaluation..
What interventions are being tested in trial NCT01318772?
The interventions under investigation include: Radiography and Fluoroscopy Imaging System (DEVICE).
Who is sponsoring clinical trial NCT01318772?
This trial is sponsored by Toshiba America Medical Systems, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01318772 being conducted?
This trial has 1 study location across Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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