Development of MR Systems, Accessories, and Software for Imaging Subjects With Metallic Orthopedic Implants.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Image quality of images that are obtained from scanning subjects who have metallic MR Safe or MR Conditional implants, will be evaluated on a pass/fail basis.
研究概览
简要总结
The purpose of the study is to improve image quality, increase speed of scanning and to see how well certain products test by scanning people who have an orthopedic hip or knee metallic implant.
详细描述
The technology comprising Magnetic Resonance (MR) imaging systems and accessories is under continuous development in order to improve the quality of images, speed of acquisition, and usability of MR devices applied to image subjects with metallic orthopedic implants. Collection of in vivo human data throughout the product development and maintenance lifecycle plays an important role in enabling the technology to be investigated, optimized, and validated.
This is a pre-market investigation involving commercially available devices, investigational devices, and commercial devices modified with investigational components. The Study will be conducted for three years, over which time a number of endpoints will be collected for various devices under development.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- 是
入选标准
- •At least 18 years of age; and
- •Must have an in-place knee or hip orthopedic implant; and
- •Must have a metallic orthopedic implant that is labeled as "MR safe" or "MR Conditional" by the implant manufacturer; and
- •Must be able to provide sufficient documentation of the implant such that study staff can confirm its compatibility with the specific MR environment per the implant labeling; and
- •Must be able to provide written documentation or attestation of the date their orthopedic implant was placed; and
- •Must be able to hear and understand English without assistive devices; and
- •Must provide written informed consent; and
- •Must provide the name and contact information for his/her Physician
排除标准
- •Any implant more than 5 years old
- •Any implant that is investigational
- •Any implant which cannot be verified with a manufacturer's label
- •Any implant implanted outside of U.S.A.
- •Any implant associated with a recall
- •Any history of pathology associated with an in-place orthopedic implant
- •History of pain at implant site, in the past 30 days
- •Known or suspected complication, defect, or concern regarding an in-place orthopedic implant
- •Surgery related to an orthopedic implant within the past 120 days
- •Potential for metal to be in body due to a previous injury involving metallic objects
- •Pregnancy or late menstrual period
- •Any non-orthopedic implant
- •Any type of prosthesis (eye, penile, heart valve, etc.)
- •Any other type of metal implant other than knee or hip implant
- •Presence of tissue expander (breast)
- •Intra-uterine device, diaphragm or pessary
- •Loose dental fillings or dental fillings in the last 30 days
- •Tattoo or permanent make up
- •Breathing problem or motion disorder
- •Claustrophobia or panic attacks
- •Hearing Aid
- •Body piercing jewelry
- •Dentures or partial plates
- •External medical hardware (example: orthopedic braces, orthodontic appliance)
- •Known or past allergic reactions to latex
结局指标
主要结局
Image quality of images that are obtained from scanning subjects who have metallic MR Safe or MR Conditional implants, will be evaluated on a pass/fail basis.
时间窗: Within the first hour after scanning
Review of real-time and post-acquisition technical assessment will occur. The assessment of images will be made by scientists, engineers and radiology technologists. Validation activities will consist of a comparison of the observed images with the prospective acceptance criteria to determine if each specific test results in a pass or fail. There are no statistical tests and no efficacy endpoints.
次要结局
- The ease of use and optimization of the MR device in imaging of subjects with metallic implants will be assessed.(Within one hour of scanning)