NCT01295528

Brief Summary

The clinical protocol of the clinical testing of this device:

  1. 1.Objective of the test: To verify the function of device.
  2. 2.Test methods and procedures: Performance test in two positions: Seated and Supine.
  3. 3.DUT: Transtek Blood Pressure Monitor, Model: TMB-986. Cuff size: 22-32cm and 22-42cm.
  4. 4.Comparison device: Yuyue medical BP meter, accuracy: ±1mmHg and range: 0-300mmHg.
  5. 5.Study endpoints: Comply with ANSI/AAMI SP10-2002 standard.
  6. 6.Statistical methodology used: Description of statistical methods.
  7. 7.Result: Meet the requirements of SP10.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 14, 2011

Completed
Last Updated

February 14, 2011

Status Verified

February 1, 2011

Enrollment Period

Same day

First QC Date

January 26, 2011

Last Update Submit

February 11, 2011

Conditions

Hypertension

Keywords

blood pressureheart rate

Outcome Measures

Primary Outcomes (1)

  • Verify the accuracy of measure functions of device

    Verify the accuracy of device if meet the requirements of ANSI/AAMI SP10 when it measure Systolic \& Diastolic blood pressure.

    10 days

Study Arms (1)

Blood Pressure, Heart Rate, Monitor

Device: Comparison test

Interventions

Comparison testDEVICE

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

Also known as: Brand names: Yuyue, Serial numbers: YYBP20091123089, Code name: BP212
Blood Pressure, Heart Rate, Monitor

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The subject population included patients suffering from hypertension, labile hypertension, normal, and hypotension. The 95 patients had a wide range in age, weight, height, heart rate, systolic and diastolic blood pressures. 18\~99 years old. Male or Female. Arm circumference in 22-42cm.

You may qualify if:

  • male,female,

You may not qualify if:

  • below 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhou District Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

  • Alpert BS. Validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitor to the ISO Standard and BHS protocol. Blood Press Monit. 2010 Oct;15(5):275-7. doi: 10.1097/MBP.0b013e32833c8b39.

    PMID: 20559140BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Guoqing Li, Director

    Wuhou District Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2011

First Posted

February 14, 2011

Study Start

May 1, 2010

Primary Completion

May 1, 2010

Study Completion

October 1, 2010

Last Updated

February 14, 2011

Record last verified: 2011-02

Locations

CN(1)