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

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ClinicalTrials.gov Identifier: NCT01502553
Recruitment Status : Completed
First Posted : December 30, 2011
Last Update Posted : December 30, 2011
Sponsor:
Collaborator:
BTS International
Information provided by (Responsible Party):
Leo Wang, BTS International

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.

Condition or disease Intervention/treatment Phase
Hypertension Device: Comparison Test to Yuyue Medical BP Meter, YYBP-212 Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Verify the Functions of BPM LS-802 to Comply With ANSI/AAMI SP10
Study Start Date : October 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : November 2011

Arm Intervention/treatment
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




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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male,female,

Exclusion Criteria:

  • below 18 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: BTSInternational )
First Posted: December 30, 2011    Key Record Dates
Last Update Posted: December 30, 2011
Last Verified: December 2011

Keywords provided by Leo Wang, BTS International:
blood pressure
heart rate