CTRI/2020/12/029746已完成不适用
A prospective, post market, non-interventional observational, open label, single arm, single center study to validate the clinical safety and performance of Intraskan DC
Skanray Technologies Pvt Ltd1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年12月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Collection of feedback which includes investigator’s assessment of the overall safety and performance of the devices Intraskan DC found to be appropriate to meet the predefined objectives.
研究概览
简要总结
This is a post market clinical follow up investigation to validate the safety and performance of Intraskan DC.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female subjects of all age groups.
- •Subjects or legally authorized representatives or guardians on behalf of the subject who are able and willing to provide written informed consent to participate in this clinical investigation.
排除标准
- •Pregnant or suspected to be pregnant based on the opinion of a physician.
- •Infant of age less than 1 year.
结局指标
主要结局
Collection of feedback which includes investigator’s assessment of the overall safety and performance of the devices Intraskan DC found to be appropriate to meet the predefined objectives.
时间窗: Within 14 days after capturing the radiographic | images.
次要结局
- Collection of feedback from the investigator on the radiographic images collected during the study and usability. This shall meet the predefined objectives to prove the claimed performance of Intraskan DC(Within 14 days after capturing the radiographic images.)
研究者
研究点 (1)
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