Pilot Study Comparing Diagnostic Imagining Versus FujiFilm's Digital Radiographic AcSellerate CsI System With Tomosynthesis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Number of Participants for Whom Tibia Injury Was Detected
研究概览
简要总结
To acquire and build a library of image sets to determine if Fuji's TOMO imaging device can replace or compliment current imaging standards to assess patients with hip, wrist or tibia injuries.
详细描述
Subjects presenting with a wrist injury, tibial fracture, or hip injury that require protocol defined standard imaging will have an X-Ray, CT Scan (or MRI per site preference) and TOMO completed. Images will be assessed to determine if TOMO is appropriate to supplement or replace the need for the other standard images.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician request to have diagnostic imaging for condition areas
排除标准
- •Pregnancy
- •Insufficient Anatomical Coverage or Potential Image Problems
结局指标
主要结局
Number of Participants for Whom Tibia Injury Was Detected
时间窗: Baseline Imaging Collection
Clinical utility where the DTS could replace and/or complement existing imaging procedures; for example, Computed Tomography for fractures of the tibial plateau or scaphoid - where radiation dose, access to modality and cost play a factor in planning initial diagnosis and/or follow-up imaging strategies. Subsequent independent review by the principal investigator (PI) \[or designee\] to show the ability of the Fujifilm DTS system to provide images of clinical equivalence compared to those acquired on other FDA cleared imaging systems.
次要结局
未报告次要终点