NCT02971527

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

February 28, 2017

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2017

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

9 days

First QC Date

November 17, 2016

Last Update Submit

April 12, 2017

Conditions

Clinical TrialComparative Effectiveness ResearchEquipment Safety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • 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

  • clinical symptoms

    before detection, during detection and 0-24 hours after detection

  • +2 more secondary outcomes

Study Arms (2)

Oste-scan 500A-SONOST3000

EXPERIMENTAL

In this group, the investigators will measure calcaneal bone strength index of each subject by experimental device firstly and then by control device.

Device: Oste-scan 500ADevice: SONOST3000

SONOST3000-Oste-scan 500A

EXPERIMENTAL

In this group, the investigators will measure calcaneal bone strength index of each subject by control device firstly and then by experimental device.

Device: Oste-scan 500ADevice: SONOST3000

Interventions

Oste-scan 500ADEVICE

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).

Oste-scan 500A-SONOST3000SONOST3000-Oste-scan 500A
SONOST3000DEVICE

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.

Oste-scan 500A-SONOST3000SONOST3000-Oste-scan 500A

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Study Officials

  • Huijie Zhang, Doctor

    Office Director of Clinical Trial Institution

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Office Director of Clinical Trial Institution

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 23, 2016

Study Start

February 28, 2017

Primary Completion

March 9, 2017

Study Completion

March 9, 2017

Last Updated

April 13, 2017

Record last verified: 2017-04

Locations

CN(1)