Evaluation of a New Blood Pressure Measuring Device. | NCT00265707

Studies
Evaluation of a New Blood Pressure Measuring Device.

NCT00265707

Sponsor

Maaynei Hayesha Medical Center

Status

Unknown status

Last Update Posted

Oct 9, 2006Estimated

Enrollment

120

Phase

Not Applicable

Conditions

Hypertension

Interventions

Blood pressure measurement

Countries

Israel

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

Dec 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Dec 2005

First Submitted Date

Dec 14, 2005

First Submission Date that Met QC Criteria

Dec 14, 2005

First Posted Date

Dec 15, 2005Estimated

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

Oct 6, 2006

Last Update Posted Date

Oct 9, 2006Estimated

Description Module

Brief Summary

A disposable blood pressure measuring device will be tested and compared to a standard mercury sphygmomanometer.
Up to 100 subjects with various levels of blood pressure values will be tested.

Detailed Description

The study will comprise 85 to 100 subjects with blood pressure values ranging between 90 and 170mmHg -systolic and 65-95 -diastolic.

Three sets of measurements will be performed on each subject. The measurement with the tested device placed between twh determinations with a mercury sphygmomanometer.
Each measurement will be performed simultaneously by two examiners specially trained.
Informed consent will be obtained from all participants.
The results will be evaluated by a standard statistical plan ANSI/AAMI SP-10 2002.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Blood pressure measurement	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The difference between the paired measurements with the tested device and the reference measurements (with a mercury sphygmomanometer) will differ by no more than +-5mmHg.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, age 18 years or above
Signed written informed consent

Exclusion Criteria:

A history of cardiac arrythmia
Wrist circumference smaller than 13cm or larger than 19.5cm
Documented peripheral vascular disease
Damage or injury to the left wrist
Participation in any other clinical study
Any acute coronary of cardiovascular illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mordchai Ravid, MD FACP	Contact	972-3-5771113		ravid@mhmc.co.il
Itzhak Klinger, MD	Contact	972-3-5771216		klinger@mhmc.co.il

Overall Officials

Name	Affiliation	Role
Mordchai Ravid, MD FACP	Maaynei Hayesha Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine, Maaynei Hayesha Hospital	Recruiting	Tel Aviv		51544	Israel

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D007022	Hypotension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001795	Blood Pressure Determination

Ancestor Terms

ID	Term
D003935	Diagnostic Techniques, Cardiovascular
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D010808	Physical Examination

Browse Leaves

Not provided

Browse Branches

Not provided