Evaluation of a New Blood Pressure Measuring Device.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2005 by Maaynei Hayesha Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Maaynei Hayesha Medical Center
ClinicalTrials.gov Identifier:
NCT00265707
First received: December 14, 2005
Last updated: October 6, 2006
Last verified: December 2005
  Purpose
  • 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.

Condition Intervention
Hypertension
Device: Blood pressure measurement

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
Official Title: A Study to Evaluate the Safety and Effectiveness (Overall Performance) of the Press-O-Sense Non-Invasive Blood Pressure Measuring Device.

Resource links provided by NLM:


Further study details as provided by Maaynei Hayesha Medical Center:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 120
Study Start Date: September 2005
Estimated Study Completion Date: December 2005
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265707

Contacts
Contact: Mordchai Ravid, MD FACP 972-3-5771113 ravid@mhmc.co.il
Contact: Itzhak Klinger, MD 972-3-5771216 klinger@mhmc.co.il

Locations
Israel
Department of Medicine, Maaynei Hayesha Hospital Recruiting
Tel Aviv, Israel, 51544
Contact: Itzhak Klinger, MD    972-3-5771216    klinger@mhmc.co.il   
Principal Investigator: Mordchai Ravid, MD FACP         
Sponsors and Collaborators
Maaynei Hayesha Medical Center
Investigators
Principal Investigator: Mordchai Ravid, MD FACP Maaynei Hayesha Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00265707     History of Changes
Other Study ID Numbers: DPTYN001CTIL
Study First Received: December 14, 2005
Last Updated: October 6, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Maaynei Hayesha Medical Center:
Hypertension
Hypotension

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014