Use of Digital Tomosynthesis for Detection and Case Management of Scaphoid and Distal Radius Fractures: A VolumeRAD Data Collection Study
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Number of CT (or MRI) images
研究概览
简要总结
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information using the VolumeRAD advanced application.
详细描述
The study described herein is being conducted to collect clinical data associated with diagnosis and treatment information to support additional, on-label claims for GEHC's VolumeRAD advanced application. The results of this study are intended for use in the submission of FDA 510(k) claims in the United States.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •for Control-arm Subjects:
- •Subjects who meet all of the following inclusion criteria may be enrolled in this study:
- •Are adults aged 18 years or older;
- •Are able and willing to comply with study procedures; and
- •Are able and willing to provide written informed consent to participate in this study.
排除标准
- •for Control-arm Subjects:
- •Subjects who meet any of the following exclusion criteria will be excluded from this study:
- •Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;
- •Have had known prior trauma in either wrist.
- •Inclusion Criteria for Test-arm Subjects:
- •Subjects who meet all of the following inclusion criteria may be enrolled in this study:
- •Are adults aged 18 years or older;
- •Have a confirmed or suspected distal radius or scaphoid wrist fracture;
- •Have completed an X-ray imaging exam per standard of care;
- •Have a standard of care (SOC) CT or MRI exam ordered;
- •Are able and willing to complete DTS imaging exam (if not already completed);
- •Are able and willing to comply with study procedures; and
- •Are able and willing to provide written informed consent to participate in this study.
- •Exclusion Criteria for Test-arm Subjects:
- •Subjects who meet any of the following exclusion criteria will be excluded from this study:
- •Are documented as pregnant based on PI's medical judgment and in consideration of local clinical practice standards for evidence of pregnancy;
- •Have additional trauma within the image field of view that either impacts the visualization or changes the treatment of the scaphoid or distal radius fracture;
- •Have had prior reconstructive surgery or fixation in the wrist.
研究组 & 干预措施
Control-arm group
The control-arm group will consist of healthy volunteers with no known prior trauma in the wrists. The diagnostic truth for subjects in the control-arm will be no fracture and the treatment truth will be no treatment.
干预措施: DTS (Device)
Control-arm group
The control-arm group will consist of healthy volunteers with no known prior trauma in the wrists. The diagnostic truth for subjects in the control-arm will be no fracture and the treatment truth will be no treatment.
干预措施: X-ray (Device)
Test-arm group
The test-arm group will consist of subjects who present with a wrist injury and initial SOC X-ray imaging results show a confirmed or suspected distal radius or scaphoid fracture, for which additional diagnostic imaging shall be ordered. Diagnostic truth for subjects in the test-arm will be the per-subject clinical diagnosis and the treatment truth will be the per-subject treatment received.
干预措施: DTS (Device)
Test-arm group
The test-arm group will consist of subjects who present with a wrist injury and initial SOC X-ray imaging results show a confirmed or suspected distal radius or scaphoid fracture, for which additional diagnostic imaging shall be ordered. Diagnostic truth for subjects in the test-arm will be the per-subject clinical diagnosis and the treatment truth will be the per-subject treatment received.
干预措施: X-ray (Device)
Test-arm group
The test-arm group will consist of subjects who present with a wrist injury and initial SOC X-ray imaging results show a confirmed or suspected distal radius or scaphoid fracture, for which additional diagnostic imaging shall be ordered. Diagnostic truth for subjects in the test-arm will be the per-subject clinical diagnosis and the treatment truth will be the per-subject treatment received.
干预措施: MRI or CT (Device)
结局指标
主要结局
Number of CT (or MRI) images
时间窗: 1 year
collection of image sets from CT (or MRI) imaging exams for each complete and evaluable subject case
Number of DTS images
时间窗: 1 year
Collection of image sets from DTS imaging exams for each complete and evaluable subject case
Number of X-ray Images
时间窗: 1 year
collection of image sets from X-ray imaging exams for each complete and evaluable subject case
次要结局
- Questionnaire about Diagnosis(1 year)
- Questionnaire about Treatment(1 year)