Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children

This study has been completed.
Sponsor:
Collaborator:
University of Tennessee Health Science Center
Information provided by (Responsible Party):
Tiba Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00944983
First received: July 21, 2009
Last updated: May 6, 2014
Last verified: May 2014

July 21, 2009
May 6, 2014
July 2009
December 2009   (final data collection date for primary outcome measure)
Series of blood pressure measurements obtained in 100+ subjects [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00944983 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children
Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children

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.

Not Provided
Observational
Not Provided
Not Provided
Retention:   None Retained
Description:

Only blood pressure measurements are retained

Non-Probability Sample

Adults, Adolescents, and Children of different genders, ages, races & sizes (height, weight & particularly arm size) plus blood pressure ranges (normatensive, hypotensive and hypertensive).

Hypertension
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages > 3 Years Old

Exclusion Criteria:

  • Severe Arrhythmia
Both
3 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00944983
UT09-00420-XP
Yes
Tiba Medical, Inc.
Tiba Medical, Inc.
University of Tennessee Health Science Center
Principal Investigator: Bruce Alpert, MD University of Tennessee
Tiba Medical, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP