Efficacy and Safety Study of Ultrasound Bone Strength Device to Measure Calcaneal Bone Strength Index of Human Subjects
NCT ID: NCT02971527
Last Updated: 2017-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2017-02-28
2017-03-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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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.
Oste-scan 500A
The investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device. Experimental ultrasound bone strength device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G).
SONOST3000
The investigators will detect the same calcaneus of each subject by control ultrasound bone strength device. Control ultrasound bone strength device's model number is SONOST3000.
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.
Oste-scan 500A
The investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device. Experimental ultrasound bone strength device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G).
SONOST3000
The investigators will detect the same calcaneus of each subject by control ultrasound bone strength device. Control ultrasound bone strength device's model number is SONOST3000.
Interventions
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Oste-scan 500A
The investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device. Experimental ultrasound bone strength device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G).
SONOST3000
The investigators will detect the same calcaneus of each subject by control ultrasound bone strength device. Control ultrasound bone strength device's model number is SONOST3000.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
80 Years
ALL
Yes
Sponsors
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The Second Hospital of Nanjing Medical University
OTHER
Responsible Party
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Zhang Hui Jie
Office Director of Clinical Trial Institution
Principal Investigators
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Huijie Zhang, Doctor
Role: PRINCIPAL_INVESTIGATOR
Office Director of Clinical Trial Institution
Locations
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The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Other Identifiers
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HJHC-YLQX2016001
Identifier Type: -
Identifier Source: org_study_id
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