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Validation of a Vital Signs Monitoring Wristband

NCT05566886 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-05-04

Study results available
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Summary

Today, continuous monitoring of vital signs remains a challenge since it generally requires the patient to be connected to multiple wired sensors, which restricts patient mobility in the intra-mural setting and complicates home monitoring in the extra-mural setting. Wearable devices on the wrist, although emerging, are often not clinically validated or limited to the monitoring of one or two vital signs.

This study aims to validate the Corsano CardioWatch 287-2 for the continuous monitoring of heart rate at ≤ 4 bpm root mean squared error (RMSE); interbeat intervals at ≤ 50 ms RMSE; breathing rate at ≤ 2 brpm RMSE; and peripheral oxygen saturation at ≤ 3 percentage point RMSE. Also, this study aims to validate the Corsano CardioWatch 287-2 for the measurement of non-invasive blood pressure according to ISO 81060-2:2018.

Conditions

Interventions

DEVICE

Continuous measurement of photoplethysmography at the wrist

Patients receive a wristband that uses multi-color LEDs to measure pulsations at the wrist.

Sponsors & Collaborators

  • Corsano Health B.V.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-19
Primary Completion
2023-02-07
Completion
2023-02-07
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05566886 on ClinicalTrials.gov