Clinical TrialNCT02971527
Efficacy and Safety Study of Ultrasound Bone Strength Device to Measure Calcaneal Bone Strength Index of Human Subjects
A study testing Oste-scan 500A and SONOST3000 in people with Clinical Trial and Comparative Effectiveness Research, run by The Second Hospital of Nanjing Medical University at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Trial, Comparative Effectiveness Research, Equipment Safety
- What is being tested?
- Oste-scan 500A and SONOST3000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2017to 9 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
About this study
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
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).
Read the 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.
- Being tested
- Oste-scan 500A, SONOST3000
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Oste-scan 500A; Device: 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. Receives: Device: Oste-scan 500A; Device: SONOST3000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-24 hours after detection
Secondary outcomes (7)
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.
Measured: After detection
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.
Measured: After detection
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.
Measured: during detection and 0-24 hours after detection
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.
Measured: before detection, during detection and 0-24 hours after detection
clinical symptoms
Clinical symptoms will be observed and recorded before detection, during detection and 0-24 hours after detection.
Measured: before detection, during detection and 0-24 hours after detection
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.
Measured: before detection, during detection and 0-24 hours after detection
the number of participants with adverse events
Adverse events appeared in the entire trial will be recorded.
Measured: in the entire trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start28 Feb 2017
- Primary completion9 Mar 2017
- Study completion9 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical TrialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Hui Jie, The Second Hospital of Nanjing Medical University
- Investigators
- Huijie Zhang, Doctor, Principal investigator, Office Director of Clinical Trial Institution
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971527
- Sponsor's protocol ID
- HJHC-YLQX2016001
- Status last verified
- Apr 2017
- First submitted
- 17 Nov 2016
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02971527
- Acronym / sponsor ID
- HJHC-YLQX2016001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 9 Mar 2017 (actual)
- First posted
- 23 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oste-scan 500A-SONOST3000 | Experimental | Device: Oste-scan 500A, Device: SONOST3000In this group, the investigators will measure calcaneal bone strength index of each subject by experimental device firstly and then by control device. |
| SONOST3000-Oste-scan 500A | Experimental | Device: Oste-scan 500A, Device: SONOST3000In this group, the investigators will measure calcaneal bone strength index of each subject by control device firstly and then by experimental device. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oste-scan 500AThe 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 | Oste-scan 500A-SONOST3000, SONOST3000-Oste-scan 500A |
| SONOST3000The 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. | Device | Oste-scan 500A-SONOST3000, SONOST3000-Oste-scan 500A |
Primary outcome
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.
7 secondary outcomes
the accuracy of speed of sound(SOS)
Time frame: After detection
the accuracy of broadband ultrasound attenuation(BUA), stiffness(SI), T-scores and Z-scores
Time frame: After detection
the using performance evaluation index of the device, including function, stability and convenience
Time frame: during detection and 0-24 hours after detection
vital signs, including respiration, heart rate, blood pressure and temperature
Time frame: before detection, during detection and 0-24 hours after detection
clinical symptoms
Time frame: before detection, during detection and 0-24 hours after detection
skin allergy caused by the device
Time frame: before detection, during detection and 0-24 hours after detection
the number of participants with adverse events
Time frame: in the entire trial
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huijie Zhang, Doctor principal investigator
Office Director of Clinical Trial Institution
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oste-scan 500A and SONOST3000 in people with Clinical Trial and Comparative Effectiveness Research, run by The Second Hospital of Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the consistent rate of bone mineral density diagnosis (time frame: 0-24 hours after detection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.