Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children
Primary Purpose
Hypertension
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by

About this trial
This is an observational trial for Hypertension focused on measuring Hypertension, Hypotension, Clinical Validation, Blood Pressure Accuracy, ISO 81600 Standard, British Hypertension Society, European Society of Hypertension, International Protocol
Eligibility Criteria
Inclusion Criteria:
- Ages > 3 Years Old
Exclusion Criteria:
- Severe Arrhythmia
Sites / Locations
- University of Tennessee Medical Group
Outcomes
Primary Outcome Measures
Series of blood pressure measurements obtained in 100+ subjects
Secondary Outcome Measures
Full Information
NCT ID
NCT00944983
First Posted
July 21, 2009
Last Updated
May 6, 2014
Sponsor
Tiba Medical, Inc.
Collaborators
University of Tennessee
1. Study Identification
Unique Protocol Identification Number
NCT00944983
Brief Title
Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children
Official Title
Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children
Study Type
Observational
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tiba Medical, Inc.
Collaborators
University of Tennessee
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Clinical validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitoring system according to the accuracy guidelines of the ISO 80601-2-30 Standard in Adults, Adolescents, and Children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Hypotension, Clinical Validation, Blood Pressure Accuracy, ISO 81600 Standard, British Hypertension Society, European Society of Hypertension, International Protocol
7. Study Design
Enrollment
105 (Actual)
Biospecimen Retention
None Retained
Biospecimen Description
Only blood pressure measurements are retained
Primary Outcome Measure Information:
Title
Series of blood pressure measurements obtained in 100+ subjects
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages > 3 Years Old
Exclusion Criteria:
Severe Arrhythmia
Study Population Description
Adults, Adolescents, and Children of different genders, ages, races & sizes (height, weight & particularly arm size) plus blood pressure ranges (normatensive, hypotensive and hypertensive).
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Alpert, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Medical Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.iso.org/iso/catalogue_detail.htm?csnumber=44105
Description
ISO 80601-2-30 Standard
Learn more about this trial
Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children
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