A Novel Non-interfering Arterial Blood Pressure Monitoring Device

Study Overview
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Brief Summary
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The primary purpose of this investigation is to validate the performance and safety of the Investigational Device (ID) against a validated and legally cleared device for measuring Blood Pressure (BP). The secondary purpose is to validate the performance of the ID over a period of 24 hours against a validated and legally cleared device for Ambulatory Blood Pressure Monitoring (ABPM).

Detailed Description
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The clinical investigation is conducted as a controlled (subject as own control), prospective, randomised, comparative investigation in a population with a representative spread of BPs to ensure that the ID performs as good as current marketed and approved devices. The study will be conducted in compliance with the International Standard ANSI/AAMI/ISO 81060-2 - Non-invasive sphygmomanometers - Clinical validation of automated measurement type. This clinical investigation will enrol up to 96 male and female subjects to ensure the recording of 85/35 evaluable datasets in accordance with the ANSI/AAMI/ISO standard [11]. All measurements will be paired and falls into 2 categories: Auscultatory measurements as gold standard reference, oscillometric measurements for clinical practise reference and further validation of ambulatory monitoring and pulse shape measurements.

Official Title
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A Novel Non-interfering Arterial Blood Pressure Monitoring Device

Conditions
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Healthy, Hypertension, Hypotension

Intervention / Treatment
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* Device: 3M
* Device: ContiPressTM
* Device: Mobil-O-Graph


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 30% of the subjects must be males (n=29) At least 30% of the subjects must be female (n=29) Age ≥ 18 years old Limb size circumference ≥ 17 cm Blood pressure distribution: At least 25 % of the subjects should be hypertensive At least 5 % of the subjects should be hypotensive Exclusion Criteria: Breached skin Acknowledged pregnancy Pacemaker Diagnosed cardiac arrhythmia (tachycardia, bradycardia, atrial/ventricular fibrillation) Implanted metal in upper limb: Elbow prosthesis Shoulder prosthesis Metal screws Bone plates Metal chips Surgical clips Implantable Cardiac Defibrillator (ICD) Cardiac Resynchronization Therapy - Defibrillator (CRT-D) Premature ventricular contractions (PVC) Premature arterial contractions (PAC) Sensitivity or allergy towards adhesives Presence of an arterial-venous shunt Recent axillary node dissection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ContiPress vs. 3M<br>ContiPress vs. 3M passive and during exercise | Device: 3M<br>* Conventional measuring of BP<br>Device: ContiPressTM<br>* New way of measuring BP - ContiPressTM Investigational device<br>|
| Experimental: ContiPress vs. Mobil-O-Graph<br>ContiPress vs. Mobil-O-Graph passive, then oscillometric passive, then oscillometric for 24 hrs every 15 mins. | Device: 3M<br>* Conventional measuring of BP<br>Device: ContiPressTM<br>* New way of measuring BP - ContiPressTM Investigational device<br>Device: Mobil-O-Graph<br>* 2 different devices for oscillometric measurement of BP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of measurement | The reference measurements are compared with the measurements made by the investigational device | Up to 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin irritation | After removal of each investigational device the skin is assessed. Also participants are instructed to report any skin irritation to investigator | Up to 4 months |