Wrist-used Blood Pressure Monitor Clinical Test (Cuff Ran... | NCT00952965

Studies
Wrist-used Blood Pressure Monitor Clinical Test (Cuff Range: 14cm-25cm)

NCT00952965

Sponsor

Andon Health Co., Ltd

Status

Completed

Last Update Posted

Aug 6, 2009Estimated

Enrollment

86Actual

Phase

Not provided

Conditions

Blood Pressure

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Aug 5, 2009

First Submission Date that Met QC Criteria

Aug 5, 2009

First Posted Date

Aug 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2009

Last Update Posted Date

Aug 6, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to monitor the blood pressure level of the patient using a wrist cuff ranged 14 cm-25 cm.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

86Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
blood pressure monitor		wrist circumference: 14cm-25cm
stethoscopy		wrist circumference: 14cm-25cm

Interventions

Not provided

Measure	Description	Time Frame
level of blood pressure		10 s

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

wrist circumference: 14 cm-25 cm

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

81 Years

Standard Ages

AdultOlder Adult

Study Population

resident of a community.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Qi Sun	Andon Health Co., Ltd	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beichen hospital		Tianjin	Tianjin Municipality	300000	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16932037	Background	Wong SN, Tz Sung RY, Leung LC. Validation of three oscillometric blood pressure devices against auscultatory mercury sphygmomanometer in children. Blood Press Monit. 2006 Oct;11(5):281-91. doi: 10.1097/01.mbp.0000209082.09623.b4.