Clinical Study of Wrist Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 Standard (WristBPM01)
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|ClinicalTrials.gov Identifier: NCT01662947|
Recruitment Status : Completed
First Posted : August 13, 2012
Last Update Posted : August 13, 2012
The clinical protocol of the clinical testing of this device:
- Objective of the test: To verify the efficiency of device.
- Test methods and procedures: Clinical test in two positions: Seated and Supine.
- DUT: Transtek Wrist Blood Pressure Monitor, Model: TMB-1117. Cuff size: 13.5 - 21.5 cm.
- Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range: 0-300 mmHg.
- Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.
- Statistical methodology used: Description of statistical methods.
- Result: Meet the requirements of SP10.
|Condition or disease||Intervention/treatment||Phase|
|Efficacy of Wrist BPM Measurement Hypertension||Device: Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117 Device: Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Verify Wrist BPM TMB-1117 to Comply With ANSI/AAMI SP10|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
Experimental: DUT Arm
DUT: Transtek Wrist Blood Pressure Monitor TMB-1117
Measurement: Blood Pressure
Device: Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117
Systolic, Diastolic pressure.
Other Name: DUT TMB-1117 measurement
Experimental: Reference Arm
Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg.
Measurement: Blood Pressure
Device: Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2
Systolic, Diastolic pressure
Other Name: Reference mercury sphygmomanometer measurement
- Verify the accuracy of measure functions of device [ Time Frame: 10 days ]Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic & Diastolic blood pressure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01662947
|Zhongshan City People's Hospital|
|Zhongshan, Guangdong, China, 528403|
|Study Chair:||Leo Wang, Leader||BTS International|