Clinical Study of Wrist Blood Pressure Monitor in Conformance With the ANSI/AAMI SP10 Standard (WristBPM01)

This study has been completed.
Sponsor:
Collaborator:
BTS International
Information provided by (Responsible Party):
Leo Wang, BTS International
ClinicalTrials.gov Identifier:
NCT01662947
First received: August 1, 2012
Last updated: August 8, 2012
Last verified: August 2012
  Purpose

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 Intervention
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Verify Wrist BPM TMB-1117 to Comply With ANSI/AAMI SP10

Resource links provided by NLM:


Further study details as provided by BTS International:

Primary Outcome Measures:
  • Verify the accuracy of measure functions of device [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]
    Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic & Diastolic blood pressure.


Enrollment: 85
Study Start Date: May 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male,female,

Exclusion Criteria:

  • below 18 years old
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: August 1, 2012
Last Updated: August 8, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by BTS International:
blood pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014