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

NCT01662947 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2012-08-13

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117

Systolic, Diastolic pressure.

DEVICE

Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2

Systolic, Diastolic pressure

Sponsors & Collaborators

  • BTS International

    collaborator OTHER

  • Leo Wang

    lead OTHER

Principal Investigators

  • Leo Wang, Leader · BTS International

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01662947 on ClinicalTrials.gov