Clinical Evaluation of the OEC Elite Vascular Mobile Fluoroscopy System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Imaging Guidance Adequacy Assessed by Number of Questionnaires
研究概览
简要总结
The purpose of the study is to collect survey data on the use of the OEC Elite Mobile Fluoroscopy System based on the routine clinical use of the device.
详细描述
This prospective clinical study is being conducted to acquire image guidance adequacy data from physicians conducting clinically-indicated vascular, gastrointestinal (GI), urology and pain management procedures for engineering use, as deemed appropriate by the Sponsor, for the investigational OEC Elite Mobile Fluoroscopy System (OEC Elite) in the vascular configuration. Clinical procedures included in this study will involve three (3) anatomical regions of interest - extremities and neck, thorax, and abdomen and pelvis. These regions are being targeted because they represent the range of clinical applications and anatomical regions intended for OEC Elite in the vascular configuration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 18 and 75 years (≥18 and ≤75 years old);
- •Clinical indication for a vascular, gastrointestinal (GI), urology or pain management procedure for which mobile fluoroscopy has been prescribed;
- •Able and willing to comply with study procedures; and
- •Able and willing to provide written informed consent to participate.
排除标准
- •Pregnant or suspected to be pregnant based on the opinion of and as documented by a medically qualified physician investigator;
- •Expected to be at increased risk due to study participation (e.g. due to allergies, sensitivities), in the medical opinion of an investigator; or
- •Previously participated in this study, or enrolled in another active GEHC study or other research study that could be expected to interfere with participation in study procedures, in the opinion of the investigator.
结局指标
主要结局
Imaging Guidance Adequacy Assessed by Number of Questionnaires
时间窗: 2 Months
Per-subject investigator report for procedure completion using the Investigational Device
次要结局
- Number of Investigator Procedure Surveys Assessed by Survey Questionnaire(2 months)