Clinical Trial of Blood Pressure Monitor in Conformance With the ANSI/AAMI ISO 81060-2 Standard
Completed · Not applicable
Conditions studied: Blood Pressure
In brief
The clinical protocol of the trial: 1. Objective of the trial: To assess the accuracy of device. 2. Test methods and procedures: Perform comparation test on seated position by two devices at the same time. 3. DUT: Transtek Blood Pressure Monitor, Model TMB-1591-A-002, with Cuff (sizes, cm) 15-21, 20-26, 25-34, 25-34(L), 32-43, 32-43(L), 40-55. 4. Reference device: Baumanometer Desk Mercury Sphygmomanometer. 5. Study endpoints: Comply with ANSI/AAMI ISO 81060-2:2013 standard. 6. Statistical methodology used: Standard deviation, Mean error.
Key facts
- Study ID
- NCT03588559
- Run by
- BTS International
- People needed
- 88
- Starts
- 2017-05-30
- Expected to finish
- 2018-04-23
- Last updated by the study team
- 2018-07-17
Who can join
Age: 3 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- Clinimark, LLC — Louisville, Colorado, United States
Full record on ClinicalTrials.gov
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