A Multicenter, Open-Labeled, Self-Paired Study to Examine the Effectiveness and Safety of Ultrasound Bone Strength Device Used for Measuring Calcaneal Bone Strength Index of Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- the consistent rate of bone mineral density diagnosis
研究概览
简要总结
The purpose of this study is to examine whether ultrasound bone strength device (Model Number: Oste-scan 500A) is effective and safe in measuring calcaneal bone strength index of human subjects, compared with a listed, similar device (Model Number: SONOST3000).
详细描述
This study adopt a method of multicenter, open-labeled, self-paired design. Each subject will be randomly assigned to two different detective sequence groups. In one group, the investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device firstly and then by control device. In another group, the investigators will detect the same calcaneus of each subject by control ultrasound bone strength device firstly and then by experimental device. Experimental ultrasound bone strength device is developed by Wuxi Huajian Hengchuang Medical Equipment Science and Technology Co., Ltd.. This device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G). Control ultrasound bone strength device which has same clinical indications and action mechanism with the experimental one, is manufactured by Osteosys Co., Ltd.. This device's model number is SONOST3000.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject who need to measure calcaneal bone strength index.
- •Subject is a male or female subject 20-80 years of age.
- •Subject is willing and able to provide signed and dated written informed consent form.
- •Subject whose compliance is good and can cooperate to complete the clinical trial.
排除标准
- •Subject whose heel skin fester or defect.
- •Subject has a history of allergic reactions to ultrasonic coupling agent.
- •Subject who is not cooperative obviously or nervous extremely.
- •Pregnant or lactating females.
- •Subject has a mental disease, without self-control.
- •Subject has participated in other clinical trial within a month.
研究组 & 干预措施
SONOST3000-Oste-scan 500A
In this group, the investigators will measure calcaneal bone strength index of each subject by control device firstly and then by experimental device.
干预措施: Oste-scan 500A (Device)
SONOST3000-Oste-scan 500A
In this group, the investigators will measure calcaneal bone strength index of each subject by control device firstly and then by experimental device.
干预措施: SONOST3000 (Device)
Oste-scan 500A-SONOST3000
In this group, the investigators will measure calcaneal bone strength index of each subject by experimental device firstly and then by control device.
干预措施: Oste-scan 500A (Device)
Oste-scan 500A-SONOST3000
In this group, the investigators will measure calcaneal bone strength index of each subject by experimental device firstly and then by control device.
干预措施: SONOST3000 (Device)
结局指标
主要结局
the consistent rate of bone mineral density diagnosis
时间窗: 0-24 hours after detection
Calculating the consistent rate with data measured by two devices to evaluate the consistent rate of bone mineral density diagnosis.
次要结局
- clinical symptoms(before detection, during detection and 0-24 hours after detection)
- the using performance evaluation index of the device, including function, stability and convenience(during detection and 0-24 hours after detection)
- vital signs, including respiration, heart rate, blood pressure and temperature(before detection, during detection and 0-24 hours after detection)
- skin allergy caused by the device(before detection, during detection and 0-24 hours after detection)
- the number of participants with adverse events(in the entire trial)
- the accuracy of speed of sound(SOS)(After detection)
- the accuracy of broadband ultrasound attenuation(BUA), stiffness(SI), T-scores and Z-scores(After detection)
研究者
Zhang Hui Jie
Office Director of Clinical Trial Institution
The Second Hospital of Nanjing Medical University