A Novel Non-interfering Arterial Blood Pressure Monitoring Device

September 26, 2013 updated by: Sense A/S
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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ContiPress vs. 3M
ContiPress vs. 3M passive and during exercise
Device: 3M
Conventional measuring of BP
Device: ContiPressTM

New way of measuring BP - ContiPressTM

Investigational device
EXPERIMENTAL: ContiPress vs. Mobil-O-Graph
ContiPress vs. Mobil-O-Graph passive, then oscillometric passive, then oscillometric for 24 hrs every 15 mins.
Device: 3M
Conventional measuring of BP
Device: ContiPressTM

New way of measuring BP - ContiPressTM

Investigational device

Device: Mobil-O-Graph
2 different devices for oscillometric measurement of BP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of measurement
Time Frame: Up to 4 months
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
Time Frame: Up to 4 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sense A/S

Investigators

  • Principal Investigator: Michael H Olsen, Prof. MD, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2013

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

May 29, 2013

First Submitted That Met QC Criteria

September 26, 2013

First Posted (ESTIMATE)

October 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 26, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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