A Novel Non-interfering Arterial Blood Pressure Monitoring Device

N/AWithdrawnNCT01954446

Sense A/S

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Conditions

Hypertension Hypotension Healthy

Interventions

3MDEVICE

Conventional measuring of BP

ContiPressTMDEVICE

New way of measuring BP - ContiPressTM Investigational device

Mobil-O-GraphDEVICE

2 different devices for oscillometric measurement of BP

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Accuracy of measurement

The reference measurements are compared with the measurements made by the investigational device

Time frame: Up to 4 months

Secondary Outcomes

Skin irritation

After removal of each investigational device the skin is assessed. Also participants are instructed to report any skin irritation to investigator

Time frame: Up to 4 months

Data from ClinicalTrials.gov

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