A Novel Non-interfering Arterial Blood Pressure Monitoring Device

NCT ID: NCT01954446

Last Updated: 2013-10-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-12-31

Brief Summary

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

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.

Conditions

Hypertension; Hypotension; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ContiPress vs. 3M

ContiPress vs. 3M passive and during exercise

Group Type: EXPERIMENTAL

3M

Intervention Type: DEVICE

Conventional measuring of BP

ContiPressTM

Intervention Type: DEVICE

New way of measuring BP - ContiPressTM

Investigational device

ContiPress vs. Mobil-O-Graph

ContiPress vs. Mobil-O-Graph passive, then oscillometric passive, then oscillometric for 24 hrs every 15 mins.

Group Type: EXPERIMENTAL

3M

Intervention Type: DEVICE

Conventional measuring of BP

ContiPressTM

Intervention Type: DEVICE

New way of measuring BP - ContiPressTM

Investigational device

Mobil-O-Graph

Intervention Type: DEVICE

2 different devices for oscillometric measurement of BP

Interventions

3M

Conventional measuring of BP

Intervention Type: DEVICE

ContiPressTM

New way of measuring BP - ContiPressTM

Investigational device

Intervention Type: DEVICE

Mobil-O-Graph

2 different devices for oscillometric measurement of BP

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sense A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael H Olsen, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Other Identifiers

DK011

Identifier Type: -

Identifier Source: org_study_id