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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014