NCT05654714

ModPG3 Adult/Ped ISO 81060-2:2018 Study Protocol

ModPG3 Adult and Pediatric AAMI (Association for the Advancement of Medical Instrumentation) 2018 ISO Clinical Investigation Protocol of SureBP and StepBP Algorithms

• Status: Terminated
• Phase: —
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Welch Allyn · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

Summary

Automated blood pressure cuff measurements taken by an "oscillometric device" is the standard in numerous medical settings today. Studies show that oscillometric devices using algorithms are more accurate and consistent than devices using other non-invasive measuring techniques, especially in critical cases. SureBP algorithm estimates BP during cuff inflation; the second, StepBP algorithm does so during deflation. The purpose of this study is to test the algorithms contained in the ModPG3 on Adult and Pediatric subjects to determine if they meet the requirements of ISO 81060-2:2018/Amd 1:2020 Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type

Conditions

• Blood Pressure

Interventions

Type	Name	Description
DEVICE	ModPG3 Investigational Device	* Connex Vital Sign Monitor with ModPG3 * Laptop * Blood Pressure Data Collection Software (not used for test report analysis) * USB cable * Power strip * Welch Allyn FlexiPort Reusable Blood Pressure Cuffs
DEVICE	Auscultatory Equipment	* Reference Sphygmomanometer1 * Reference Cuffs2 * Dual Auscultatory Stethoscope * Tape measure * Stopwatch

Timeline

• Start date: 2023-03-06
• Primary completion: 2023-11-09
• Completion: 2023-11-09
• First posted: 2022-12-16
• Last updated: 2025-11-19
• Results posted: 2025-11-19

Locations

1 site across 1 country: Italy