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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00944983
First Posted: July 23, 2009
Last Update Posted: May 7, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Tennessee Health Science Center
Information provided by (Responsible Party):
Tiba Medical, Inc.
  Purpose
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.

Condition
Hypertension

Study Type: Observational
Official Title: Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children

Further study details as provided by Tiba Medical, Inc.:

Primary Outcome Measures:
  • Series of blood pressure measurements obtained in 100+ subjects [ Time Frame: 2 months ]

Biospecimen Retention:   None Retained
Only blood pressure measurements are retained

Enrollment: 105
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults, Adolescents, and Children of different genders, ages, races & sizes (height, weight & particularly arm size) plus blood pressure ranges (normatensive, hypotensive and hypertensive).
Criteria

Inclusion Criteria:

  • Ages > 3 Years Old

Exclusion Criteria:

  • Severe Arrhythmia
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944983


Locations
United States, Tennessee
University of Tennessee Medical Group
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
Tiba Medical, Inc.
University of Tennessee Health Science Center
Investigators
Principal Investigator: Bruce Alpert, MD University of Tennessee
  More Information

Additional Information:
Responsible Party: Tiba Medical, Inc.
ClinicalTrials.gov Identifier: NCT00944983     History of Changes
Other Study ID Numbers: UT09-00420-XP
First Submitted: July 21, 2009
First Posted: July 23, 2009
Last Update Posted: May 7, 2014
Last Verified: May 2014

Keywords provided by Tiba Medical, Inc.:
Hypertension
Hypotension
Clinical Validation
Blood Pressure Accuracy
ISO 81600 Standard
British Hypertension Society
European Society of Hypertension
International Protocol

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases