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

This study has been completed.
Sponsor:
Collaborator:
BTS International
Information provided by (Responsible Party):
Leo Wang, BTS International
ClinicalTrials.gov Identifier:
NCT01502553
First received: December 21, 2011
Last updated: December 29, 2011
Last verified: December 2011
  Purpose

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.

Condition Intervention
Hypertension
Device: Comparison Test to Yuyue Medical BP Meter, YYBP-212

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Verify the Functions of BPM LS-802 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: 95
Study Start Date: October 2011
Study Completion Date: November 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blood Pressure, Heart Rate, Monitor

Device 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

Device: Comparison Test to Yuyue Medical BP Meter, YYBP-212
DUT: Transtek Blood Pressure Monitor, LS-802. Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg.
Other Names:
  • Brand names: Yuyue
  • Serial numbers: YYBP20100013437
  • Code name: YYBP-212

  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01502553

Locations
China, Guangdong
Zhongshan City People's Hospital
Zhongshan, Guangdong, China, 528403
Sponsors and Collaborators
Leo Wang
BTS International
Investigators
Study Director: Yuedong Cao, Doctor Zhongshan City People's Hospital
  More Information

Additional Information:
Publications:
Responsible Party: Leo Wang, Director, BTS International
ClinicalTrials.gov Identifier: NCT01502553     History of Changes
Other Study ID Numbers: Trans 2011004, BTS-TRANS04
Study First Received: December 21, 2011
Last Updated: December 29, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by BTS International:
blood pressure
heart rate

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014