Clinical Study of Wrist Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 Standard
WristBPM01
Verify Wrist BPM TMB-1117 to Comply With ANSI/AAMI SP10
2 other identifiers
interventional
85
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2012
Shorter than P25 for not_applicable
1 active site
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
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 13, 2012
CompletedAugust 13, 2012
August 1, 2012
1 month
August 1, 2012
August 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Verify the accuracy of measure functions of device
Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic \& Diastolic blood pressure.
10 days
Study Arms (2)
DUT Arm
EXPERIMENTALDUT: Transtek Wrist Blood Pressure Monitor TMB-1117 Measurement: Blood Pressure Groups/Cohorts: DUT
Reference Arm
EXPERIMENTALReference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg. Measurement: Blood Pressure Groups/Cohorts: Reference
Interventions
Systolic, Diastolic pressure.
Systolic, Diastolic pressure
Eligibility Criteria
You may qualify if:
- male,female,
You may not qualify if:
- below 18 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leo Wanglead
- BTS Internationalcollaborator
Study Sites (1)
Zhongshan City People's Hospital
Zhongshan, Guangdong, 528403, China
Related Publications (1)
Alpert BS. Validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitor to the ISO Standard and BHS protocol. Blood Press Monit. 2010 Oct;15(5):275-7. doi: 10.1097/MBP.0b013e32833c8b39.
PMID: 20559140BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Leo Wang, Leader
BTS International
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Team leader
Study Record Dates
First Submitted
August 1, 2012
First Posted
August 13, 2012
Study Start
May 1, 2012
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
August 13, 2012
Record last verified: 2012-08