NCT05566886

Validation of a Vital Signs Monitoring Wristband

Multi Parameter Vital Signs Monitoring by the Corsano CardioWatch 287-2 Validation Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Corsano Health B.V. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Continuous measurement of photoplethysmography at the wrist	Patients receive a wristband that uses multi-color LEDs to measure pulsations at the wrist.

Timeline

• Start date: 2022-10-19
• Primary completion: 2023-02-07
• Completion: 2023-02-07
• First posted: 2022-10-04
• Last updated: 2025-05-04
• Results posted: 2025-05-04

Locations

1 site across 1 country: Netherlands

Regulatory

• FDA-regulated device study