NCT05735210

Polso™ Watch Blood Pressure Accuracy With Blood Pressure Change Validation

Polso™ Watch BP Accuracy With BP Change Validation ChroniSense Study - IPPMed 1/2021

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 185 (estimated)
• Sponsor: ChroniSense Medical Ltd. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Up to 185 adult test subjects to evaluate blood pressure measurement accuracy and stability of the Polso™ Watch compared to a reference blood pressure measurement.

Detailed description

The purpose of this validation study is to assess, in an adult population, the three fundamental clinical tests: 1. Blood pressure measurement accuracy ("accuracy test") 2. Measurement accuracy after blood pressure change ("change test") 3. Blood pressure measurement accuracy throughout the specified stability-period ("stability test") To provide evidence that the device can track changes in blood pressure, this study includes study conditions that specifically induce changes in blood pressure.

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	Polso™ Watch blood pressure measurement compared to a reference blood pressure measurement	The referenced blood pressure measurements are taken by dual auscultators.

Timeline

• Start date: 2022-04-26
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2023-02-21
• Last updated: 2024-03-08

Locations

1 site across 1 country: Germany