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

Clinical Trial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971527
• Other study ID #: HJHC-YLQX2016001
• Status: Completed
• Phase: N/A
• First received: November 17, 2016
• Last updated: April 12, 2017
• Start date: February 28, 2017
• Est. completion date: March 9, 2017

Study information

• Verified date: April 2017
• Source: The Second Hospital of Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 9, 2017
• Est. primary completion date: March 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Clinical Trial
• Comparative Effectiveness Research
• Equipment Safety

Intervention

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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the consistent rate of bone mineral density diagnosis	Calculating the consistent rate with data measured by two devices to evaluate the consistent rate of bone mineral density diagnosis.	0-24 hours after detection
Secondary	the accuracy of speed of sound(SOS)	SOS values measured by two devices will be tested by Paired T Test and Wilcoxon Signed Rank Test to evaluate the difference. In addition, calculating correlation coefficient and concordance correlation coefficient of SOS values measured by two devices to evaluate correlation and concordance of two devices.	After detection
Secondary	the accuracy of broadband ultrasound attenuation(BUA), stiffness(SI), T-scores and Z-scores	Plotting monotonicity curves of BUA values, SI values, T-scores and Z-scores of two devices to evaluate the correlation of two devices.	After detection
Secondary	the using performance evaluation index of the device, including function, stability and convenience	Evaluating the using performance evaluation index of the device, including function, stability and convenience.	during detection and 0-24 hours after detection
Secondary	vital signs, including respiration, heart rate, blood pressure and temperature	Vital signs, including respiration, heart rate, blood pressure and temperature will be observed and recorded before detection, during detection and 0-24 hours after detection.	before detection, during detection and 0-24 hours after detection
Secondary	clinical symptoms	Clinical symptoms will be observed and recorded before detection, during detection and 0-24 hours after detection.	before detection, during detection and 0-24 hours after detection
Secondary	skin allergy caused by the device	Skin allergy caused by the device will be observed and recorded before detection, during detection and 0-24 hours after detection.	before detection, during detection and 0-24 hours after detection
Secondary	the number of participants with adverse events	Adverse events appeared in the entire trial will be recorded.	in the entire trial