Ultrasound System Clinical Evaluation for Product Development
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To understand the image quality and workflow expectation for the products under development as compared to the similar examination performed on benchmark/reference system. The evaluation shall include receiving feedback from the Principal Investigator and other experts on findings related to image quality, workflow and performance in comparison to the benchmark/reference system.
研究概览
简要总结
During this clinical evaluation Philips engineering team members will ensure setting up of the system and provide training on the use of the systems and get direct feedback from the Principal Investigator during the evaluation period about their impressions of the evaluation system. The design objectives for this evaluation are to understand the image quality and workflow expectation for the products under development as compared to the similar examination performed on benchmark/reference system. The evaluation shall include receiving feedback from the Principal Investigator and other experts on findings related to image quality, workflow and performance in comparison to the benchmark/reference system.
The evaluation will be conducted in two steps:
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Subjects will be scanned using a benchmark/reference system.
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Same subjects will undergo similar scan using the comparative system for comparison purposes.
Total duration of scanning will not exceed 1 hour. Each subject can only be scanned again, if required during the evaluation period, with a gap of 1 day (excluding the day of previous scan).
A suggested three hundred (300) subjects shall be required for performing this clinical evaluation on these Ultrasound systems.
The investigational system will be housed in a secure room to limit exposure only to select individuals. The system should not be connected to PACS network until instructed to do so by Principal Investigator.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects must be willing and capable of providing informed consent and physically capable of performing study related activities.
- •Subjects ≥18 years of age including either sex.
- •Subjects has passed a general medical health checkup.
排除标准
- •â€¢Subjects not willing to sign the ICF or give the consent.
- •â€¢Subjects with a limited capacity or critically ill (e.g. non-ambulatory, admitted in some clinical facility).
- •â€¢Need interventional procedure.
- •â€¢Subjects with mental illness or diseases.
- •â€¢Subjects with uncontrolled hypertension and diabetic mellitus.
结局指标
主要结局
To understand the image quality and workflow expectation for the products under development as compared to the similar examination performed on benchmark/reference system. The evaluation shall include receiving feedback from the Principal Investigator and other experts on findings related to image quality, workflow and performance in comparison to the benchmark/reference system.
时间窗: 1 day
次要结局
- Not applicable(Not applicable)