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NCT04218032 Clinical Trial

Wearable Blood Pressure Monitoring

Blood Pressure Clinical Trial

Official title:
Verenpaineen Seuranta Paineanturi-matriisilla

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04218032
Other study ID # 1574/31/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2020
Est. completion date April 30, 2022

Study information
Verified date August 2022
Source University of Turku
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for blood pressure measurement.

Description:

The goal of this study is to develop and validate a new non-invasive medical instrumentation technology for assessing haemodynamic status measured from the fingertip using oscillometry. . As the finger pressing pressure is ramped up and then slowly down, an oscillometric response is recorded. From this signal the mean arterial pressure is found from which systolic and diastolic pressure is computed along with the full pressure waveform.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date April 30, 2022
Est. primary completion date April 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - written concent from the participant Exclusion Criteria: - pace maker, pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• sphygmomanometer, SpyghmoCor, CNAP500
blood pressure is measured with developed new non-invasive technology, oscillometry from the fingertip, and compared to non-invasive standard blood pressure measurement using a standard sphygmomanometer/SpyghmoCor device/CNAP500 device.

Locations
Country Name City State
Finland Turku University Hospital Turku

Sponsors (1)
Lead Sponsor Collaborator
University of Turku

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of new blood pressure measurement technology. the accuracy of new developed blood pressure measurement technology is validated against existing gold standard method by comparing systolic and diastolic blood pressure values between the two. up to 12 weeks
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