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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

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
History of Changes
  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:

U.S. FDA Resources

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


Estimated Enrollment: 100
Study Start Date: July 2009
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944983

Contacts
Contact: Bruce Alpert, MD (901) 287-6781 bsalpert@utmem.edu

Locations
United States, Tennessee
University of Tennessee Medical Group Recruiting
Memphis, Tennessee, United States, 38105
Contact: Bruce Alpert, MD     901-287-6781     bsalpert@utmem.edu    
Sponsors and Collaborators
Tiba Medical, Inc.
Investigators
Principal Investigator: Bruce Alpert, MD University of Tennessee
  More Information

Additional Information:
ISO 80601-2-30 Standard  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Dr. Bruce Alpert, The University of Tennessee - Health Sciences Center
ClinicalTrials.gov Identifier: NCT00944983     History of Changes
Other Study ID Numbers: UT09-00420-XP
Study First Received: July 21, 2009
Last Updated: July 22, 2009
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
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013