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

NCT01502553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2011-12-30

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: 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • BTS International

    collaborator OTHER

  • Leo Wang

    lead OTHER

Principal Investigators

  • Yuedong Cao, Doctor · Zhongshan People's Hospital, Guangdong, China

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2011-10-31
Completion
2011-11-30

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 NCT01502553 on ClinicalTrials.gov