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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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00944983
Enrollment
105
Registered
2009-07-23
Start date
2009-07-31
Completion date
2009-12-31
Last updated
2014-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, Hypotension, Clinical Validation, Blood Pressure Accuracy, ISO 81600 Standard, British Hypertension Society, European Society of Hypertension, International Protocol

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.

Interventions

None listed

Sponsors

University of Tennessee
CollaboratorOTHER
Tiba Medical, Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Ages \> 3 Years Old

Exclusion criteria

* Severe Arrhythmia

Design outcomes

Primary

MeasureTime frame
Series of blood pressure measurements obtained in 100+ subjects2 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026