NCT02971527

Efficacy and Safety Study of Ultrasound Bone Strength Device to Measure Calcaneal Bone Strength Index of Human Subjects

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Clinical Trial
• Comparative Effectiveness Research
• Equipment Safety

Interventions

Type	Name	Description
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).
DEVICE	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.

Timeline

• Start date: 2017-02-28
• Primary completion: 2017-03-09
• Completion: 2017-03-09
• First posted: 2016-11-23
• Last updated: 2017-04-13

Locations

1 site across 1 country: China