Blood Pressure Measurement Using Vitacam

NCT07739667 | Recruiting

• 1 other identifier: R24104L
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical investigation is to collect data for the development, testing, and validation of a blood pressure measurement algorithm for a contactless vital signs monitor, Vitacam, according to the ISO 80601-2:2019 standard for validating non-invasive sphygmomanometer, with the intention of disseminating the validation results through a peer-reviewed scientific publication.

Conditions

Blood Pressure Measurement

Keywords

blood pressure; remote photoplethysmography; rppg

Outcome Measures

Primary Outcomes (2)

• SBP criterion 1: Mean difference and standard deviation between cuffless device systolic blood pressure and reference blood pressure measurement.

  The mean BP difference must be 5 mm/hg or less, and its standard deviations 8 mm/hg or less (criterion 1, section 5.2.4.2, EN ISO 80601-2:2019).

  A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded.

• DBP criterion 1: Mean difference and standard deviation between cuffless device diastolic blood pressure and reference blood pressure measurement.

  The mean BP difference must be 5 mm/hg or less, and its standard deviations 8 mm/hg or less (criterion 1, section 5.2.4.2, EN ISO 80601-2:2019).

  A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded

Secondary Outcomes (1)

• Criterion 2: Inter-subject variability of device-reference blood pressure differences

  A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded.

Study Arms (1)

Adults Undergoing Blood Pressure Validation Testing

Adult participants undergoing blood pressure measurements with the investigational blood pressure device and reference blood pressure assessment for evaluation of measurement accuracy.

Device: rPPG blood pressure measurement medical device software

Interventions

rPPG blood pressure measurement medical device software DEVICE

The investigational blood pressure measuring device uses remote photoplethysmography from video and does not use an inflatable arm cuff.

Adults Undergoing Blood Pressure Validation Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents or visitors in the Tampere Pirkanmaa region

You may qualify if:

• Age 18 years or older
• Ability to give informed consent
• Volunteering for the study
• Fluent Finnish or English

You may not qualify if:

• Age under 18 years
• Pregnancy
• Inability to give informed consent
• Denial

Sponsors & Collaborators

• Evondos Oy: lead
• Tampere University: collaborator

Study Sites (1)

Tampere University

Tampere, Finland

RECRUITING

Study Officials

• Antti Vehkaoja

  Tampere University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moyeen Ahmad

CONTACT

+35850486879; moyeen.ahmad@evondos.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2026
• First Posted: July 31, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)