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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- the consistent rate of bone mineral density diagnosis
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: SONOST3000 (Device)
Outcomes
Primary Outcomes
the consistent rate of bone mineral density diagnosis
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Zhang Hui Jie
Office Director of Clinical Trial Institution
The Second Hospital of Nanjing Medical University