Evaluation of Continuous Non Invasive Blood Pressure With Adult Volunteers

Clinical Evaluation of Continuous Non-Invasive Blood Pressure Monitors With Adult Volunteers

A study to collect data recorded by devices for cNIBP evaluation purposes.

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure
• Intervention / Treatment: Device: measuring blood pressure with noninvasive blood pressure device

Detailed Description

The study is going to be conducted to collect data from the devices used in the study for future AMS engineering purposes as deemed appropriate by the Sponsor.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Juha Pärkkä; Phone Number: +35840-7530525; Email: juha.parkka@vtt.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female, aged 18 years or older (≥18 years);
• Willing and able to give informed consent for participation in the study;
• Able and willing to comply with all the study requirements.

Exclusion Criteria:

• Who is pregnant or lactating;
• Who is a smoker;
• Who has consumed alcohol in the last 24 hours;
• Who has been previously diagnosed with Ataxia or balance disorder;
• Who has been previously diagnosed with Raynaud's disease/ syndrome/ phenomenon;
• Who has been previously a diagnosed cardiovascular condition requiring medication or has an internal pacemaker;
• Who has an injury, deformity, A-V fistula, or other characteristic limiting the placing of cuffs on arms/fingers;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ambulatory monitoring solution; this study has only one arm	Device: measuring blood pressure with noninvasive blood pressure device; To measure blood pressure in different circumstances with noninvasive blood pressure device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data collection of NIBP measurement	To collect data recorded by devices for cNIBP evaluation purposes.	through study completion, average of one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collect number of adverse events (AEs), serious adverse events (SAEs), and device issues	The safety objective is to collect safety information, including type and number of adverse events (AE), serious adverse events (SAE), and device issues.	through study completion, an average of one day

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Juha Pärkkä, VTT

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2021
• Primary Completion (ANTICIPATED): July 31, 2021
• Study Completion (ANTICIPATED): September 1, 2021

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 29, 2021
• First Posted (ACTUAL): May 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 6, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 210080046

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No