NCT00265707

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Sep 2005

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 15, 2005

Completed
Last Updated

October 9, 2006

Status Verified

December 1, 2005

First QC Date

December 14, 2005

Last Update Submit

October 6, 2006

Conditions

Hypertension

Keywords

HypertensionHypotension

Outcome Measures

Primary Outcomes (1)

  • 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.

Interventions

Blood pressure measurementDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Maaynei Hayesha Hospital

Tel Aviv, 51544, Israel

RECRUITING

MeSH Terms

Conditions

HypertensionHypotension

Interventions

Blood Pressure Determination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPhysical Examination

Study Officials

  • Mordchai Ravid, MD FACP

    Maaynei Hayesha Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mordchai Ravid, MD FACP

CONTACT

972-3-5771113ravid@mhmc.co.il

Itzhak Klinger, MD

CONTACT

972-3-5771216klinger@mhmc.co.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2005

First Posted

December 15, 2005

Study Start

September 1, 2005

Study Completion

December 1, 2005

Last Updated

October 9, 2006

Record last verified: 2005-12

Locations

IL(1)