Accuracy of Non-Invasive Blood Pressure Measurement in Adults
NIBP
Clinical Evaluation of the Sotera VisiTM System for Measurement of Systolic and Diastolic Blood Pressures in Adults
2 other identifiers
observational
150
1 country
1
Brief Summary
The purpose of this study is to compare the accuracy of the Sotera ViSi, an investigational device, to auscultation (measurement with a cuff) in determining systolic and diastolic blood pressure (BP) in adult subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2010
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2010
CompletedFirst Posted
Study publicly available on registry
August 18, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJune 22, 2011
June 1, 2011
1 month
August 13, 2010
June 21, 2011
Conditions
Keywords
Eligibility Criteria
Eligible subjects are adults of any ethnic background who consent to spot-check blood pressure measurements and in whom paired blood pressure measurements with the ViSi will be feasible during a single visit. Subjects need to be greater than 12 years of age on the date of measurement and need to meet all the other inclusion and exclusion criteria.
You may qualify if:
- Subject is greater than 12 years of age at the time of screening.
- Subject's upper arm circumference is between 20cm and 55cm.
- Subject is willing to undergo the Informed Consent process prior to enrollment in the study.
- Subject is willing and able to participate for up to 60 minutes.
You may not qualify if:
- Subject is participating in another clinical study that may interfere with the results of this study.
- Subject is unable to have a blood pressure measurement taken from either arm for any reason.
- Subject is evaluated by the Investigator and found to be medically unsuitable for participation in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scripps Clinic Rancho Bernardo
San Diego, California, 92128, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret Drehobl, M.D.
Scripps Health
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 13, 2010
First Posted
August 18, 2010
Study Start
September 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
June 22, 2011
Record last verified: 2011-06