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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
Sponsor:
Collaborator:
BTS International
Information provided by (Responsible Party):
Leo Wang, BTS International

Brief Summary:

The clinical protocol of the clinical testing of this device:

  1. Objective of the test: To verify the efficiency of device.
  2. Test methods and procedures: Clinical test in two positions: Seated and Supine.
  3. DUT: Transtek Wrist Blood Pressure Monitor, Model: TMB-1117. Cuff size: 13.5 - 21.5 cm.
  4. Comparison device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1 mmHg and range: 0-300 mmHg.
  5. Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.
  6. Statistical methodology used: Description of statistical methods.
  7. 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
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Arm Intervention/treatment
Experimental: DUT Arm

DUT: Transtek Wrist Blood Pressure Monitor TMB-1117

Measurement: Blood Pressure

Groups/Cohorts: DUT

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

Groups/Cohorts: Reference

Device: Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2
Systolic, Diastolic pressure
Other Name: Reference mercury sphygmomanometer measurement



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male,female,

Exclusion Criteria:

  • below 18 years old

Information from the National Library of Medicine

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


Locations
China, Guangdong
Zhongshan City People's Hospital
Zhongshan, Guangdong, China, 528403
Sponsors and Collaborators
Leo Wang
BTS International
Investigators
Study Chair: Leo Wang, Leader BTS International

Additional Information:
Publications:
Responsible Party: Leo Wang, Team leader, BTS International
ClinicalTrials.gov Identifier: NCT01662947     History of Changes
Other Study ID Numbers: Wrist BPM TMB-1117
BTS-TRANS12001 ( Other Identifier: BTSInternational )
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: August 13, 2012
Last Verified: August 2012

Keywords provided by Leo Wang, BTS International:
blood pressure