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

NCT01295528 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 95

Last updated 2011-02-14

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 function of device.
2. Test methods and procedures: Performance test in two positions: Seated and Supine.
3. DUT: Transtek Blood Pressure Monitor, Model: TMB-986. Cuff size: 22-32cm and 22-42cm.
4. Comparison device: Yuyue medical BP meter, accuracy: ±1mmHg and range: 0-300mmHg.
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

Comparison test

Yuyue medical BP meter, accuracy: ±1mmHg and range: 0-300mmHg.

Sponsors & Collaborators

  • West China Hospital

    collaborator OTHER

  • BTS International

    lead OTHER

Principal Investigators

  • Guoqing Li, Director · Wuhou District Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2010-05-31
Completion
2010-10-31

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 NCT01295528 on ClinicalTrials.gov