Evaluation of Continuous Non Invasive Blood Pressure With Adult Volunteers

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04876664

Enrollment

Registered

2021-05-06

Start date

2021-06-01

Completion date

2021-09-01

Last updated

2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure

Brief summary

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

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.

Interventions

DEVICEmeasuring blood pressure with noninvasive blood pressure device

To measure blood pressure in different circumstances with noninvasive blood pressure device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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;

Design outcomes

Primary

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

Secondary

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

Contacts

Primary ContactJuha Pärkkä

juha.parkka@vtt.fi+35840-7530525

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026