Clinical Study of Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10
BPM_S
Verify the Functions of BPM LS-802 to Comply With ANSI/AAMI SP10
2 other identifiers
interventional
95
1 country
1
Brief Summary
The clinical protocol of the clinical testing of this device:
- 1.Objective of the test: To verify the function of device.
- 2.Test methods and procedures: Performance test in two positions: Seated and Supine.
- 3.DUT: Transtek Blood Pressure Monitor, Model: LS-802. Cuff size: 22-32 cm and 22-42 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 P25-P50 for not_applicable hypertension
Started Oct 2011
Shorter than P25 for not_applicable hypertension
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
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 21, 2011
CompletedFirst Posted
Study publicly available on registry
December 30, 2011
CompletedDecember 30, 2011
December 1, 2011
Same day
December 21, 2011
December 29, 2011
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 (1)
Blood Pressure, Heart Rate, Monitor
EXPERIMENTALDevice Comparison Test DUT: Transtek Blood Pressure Monitor, LS-802 Refrence Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg. Groups/Cohorts: Blood Pressure \& Heart Rate Monitor
Interventions
DUT: Transtek Blood Pressure Monitor, LS-802. Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg.
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 DIRECTOR
Yuedong Cao, Doctor
Zhongshan People's Hospital, Guangdong, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
December 21, 2011
First Posted
December 30, 2011
Study Start
October 1, 2011
Primary Completion
October 1, 2011
Study Completion
November 1, 2011
Last Updated
December 30, 2011
Record last verified: 2011-12