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

Completed

• Conditions: Hypertension

• Registration Number: NCT00944983
• Lead Sponsor: Tiba Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-06
• Last Update Posted: 2014-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Ages > 3 Years Old

Exclusion Criteria

• Severe Arrhythmia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Series of blood pressure measurements obtained in 100+ subjects	2 months

Trial Locations

Locations (1)

University of Tennessee Medical Group; 🇺🇸 Memphis, Tennessee, United States