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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:
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
  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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Tiba Medical, Inc.
ClinicalTrials.gov Identifier: NCT00944983     History of Changes
Other Study ID Numbers: UT09-00420-XP
Study First Received: July 21, 2009
Last Updated: May 6, 2014
Health Authority: United States: Institutional Review Board

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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014