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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

Primary Purpose

Hypertension

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
Tiba Medical, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Hypertension focused on measuring Hypertension, Hypotension, Clinical Validation, Blood Pressure Accuracy, ISO 81600 Standard, British Hypertension Society, European Society of Hypertension, International Protocol

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ages > 3 Years Old

Exclusion Criteria:

  • Severe Arrhythmia

Sites / Locations

  • University of Tennessee Medical Group

Outcomes

Primary Outcome Measures

Series of blood pressure measurements obtained in 100+ subjects

Secondary Outcome Measures

Full Information

First Posted
July 21, 2009
Last Updated
May 6, 2014
Sponsor
Tiba Medical, Inc.
Collaborators
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT00944983
Brief Title
Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children
Official Title
Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children
Study Type
Observational

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tiba Medical, Inc.
Collaborators
University of Tennessee

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Hypotension, Clinical Validation, Blood Pressure Accuracy, ISO 81600 Standard, British Hypertension Society, European Society of Hypertension, International Protocol

7. Study Design

Enrollment
105 (Actual)
Biospecimen Retention
None Retained
Biospecimen Description
Only blood pressure measurements are retained
Primary Outcome Measure Information:
Title
Series of blood pressure measurements obtained in 100+ subjects
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages > 3 Years Old Exclusion Criteria: Severe Arrhythmia
Study Population Description
Adults, Adolescents, and Children of different genders, ages, races & sizes (height, weight & particularly arm size) plus blood pressure ranges (normatensive, hypotensive and hypertensive).
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Alpert, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Medical Group
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.iso.org/iso/catalogue_detail.htm?csnumber=44105
Description
ISO 80601-2-30 Standard

Learn more about this trial

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

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