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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Tiba Medical, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tiba Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00944983
First received: July 21, 2009
Last updated: July 22, 2009
Last verified: July 2009

July 21, 2009
July 22, 2009
July 2009
September 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
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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
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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.
 
Recruiting
100
September 2009
September 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: Bruce Alpert, MD (901) 287-6781 bsalpert@utmem.edu
United States
 
NCT00944983
UT09-00420-XP
Yes
Dr. Bruce Alpert, The University of Tennessee - Health Sciences Center
Tiba Medical, Inc.
Not Provided
Principal Investigator: Bruce Alpert, MD University of Tennessee
Tiba Medical, Inc.
July 2009

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