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A Novel Non-interfering Arterial Blood Pressure Monitoring Device

Primary Purpose

Hypertension, Hypotension, Healthy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3M
ContiPressTM
Mobil-O-Graph
Sponsored by
Sense A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    ContiPress vs. 3M

    ContiPress vs. Mobil-O-Graph

    Arm Description

    ContiPress vs. 3M passive and during exercise

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

    Outcomes

    Primary Outcome Measures

    Accuracy of measurement
    The reference measurements are compared with the measurements made by the investigational device

    Secondary Outcome Measures

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

    Full Information

    First Posted
    May 29, 2013
    Last Updated
    September 26, 2013
    Sponsor
    Sense A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01954446
    Brief Title
    A Novel Non-interfering Arterial Blood Pressure Monitoring Device
    Official Title
    A Novel Non-interfering Arterial Blood Pressure Monitoring Device
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The investigational devices need alterations before validation
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    December 2013 (Anticipated)
    Study Completion Date
    December 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sense A/S

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Hypotension, Healthy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ContiPress vs. 3M
    Arm Type
    Experimental
    Arm Description
    ContiPress vs. 3M passive and during exercise
    Arm Title
    ContiPress vs. Mobil-O-Graph
    Arm Type
    Experimental
    Arm Description
    ContiPress vs. Mobil-O-Graph passive, then oscillometric passive, then oscillometric for 24 hrs every 15 mins.
    Intervention Type
    Device
    Intervention Name(s)
    3M
    Intervention Description
    Conventional measuring of BP
    Intervention Type
    Device
    Intervention Name(s)
    ContiPressTM
    Intervention Description
    New way of measuring BP - ContiPressTM Investigational device
    Intervention Type
    Device
    Intervention Name(s)
    Mobil-O-Graph
    Intervention Description
    2 different devices for oscillometric measurement of BP
    Primary Outcome Measure Information:
    Title
    Accuracy of measurement
    Description
    The reference measurements are compared with the measurements made by the investigational device
    Time Frame
    Up to 4 months
    Secondary Outcome Measure Information:
    Title
    Skin irritation
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael H Olsen, Prof. MD
    Organizational Affiliation
    Odense University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Novel Non-interfering Arterial Blood Pressure Monitoring Device

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