Clinical Evaluation of the OEC Elite MD for Vascular Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Image Guidance Adequacy Collected Via Survey Questionnaire
研究概览
简要总结
The purpose of this study is to collect feedback on imaging guidance adequacy from physicians who use the OEC™ Elite CFD Mobile Fluoroscopy System-Motorized Configuration to perform surgical procedures for which the use of mobile fluoroscopy is prescribed per standard of care.
Up to 40 eligible subjects will be enrolled and have their clinically indicated procedure completed using the investigational device.
Following completion of each subject's procedure, the investigators will complete a User Survey specific to the workflow and guidance adequacy of the OEC Elite device. The survey will consist of a series of questions on the use of the system as well as anonymized image data.
After all subjects' procedures are completed at a given site, the site investigator will review survey data from the study subjects enrolled at the site and document his/her assessment of the overall acceptability of the system for use in a clinical environment.
There is no statistical hypothesis being tested in this study. Results will be summarized using descriptive statistics.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 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 85 years (≥18 and ≤85 years old);
- •Clinical indication for procedures including vascular, gastrointestinal (GI), urology or pain management for which mobile fluoroscopy has been prescribed for image guidance;
- •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
Image Guidance Adequacy Collected Via Survey Questionnaire
时间窗: Approximately 2 months (duration of subject enrollment)
Number of participants whose procedures were completed using the investigational device.
次要结局
- Number of Investigator Procedure Surveys Assessed by Survey Questionnaire(Approximately 2 months (duration of subject enrollment))