NCT01318772已完成不适用
Clinical Image Evaluation for the KALARE (DREX-KL80) With New Digital Camera and Image Processor
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Collection of representative images
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patient 18 years and older
- •Not pregnant
- •Not a safety risk patient
排除标准
- •Male and female patient under 18 years old
- •Pregnant subjects
- •High safety risk subjects
- •Subjects and/or Legal Guardian Unable to provide informed consent
结局指标
主要结局
Collection of representative images
时间窗: Estimated completion 4 weeks after start of the study
Collect 30 to 60 represenative images to support pre-market submission.
次要结局
未报告次要终点
研究者
研究点 (1)
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