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A Novel Non-interfering Arterial Blood Pressure Monitoring Device

S

Sense A/S

Status

Withdrawn

Conditions

Hypotension
Hypertension
Healthy

Treatments

Device: ContiPressTM
Device: Mobil-O-Graph
Device: 3M

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

18+ years old

Volunteers

Accepts 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

0 participants in 2 patient groups

ContiPress vs. 3M
Experimental group
Description:
ContiPress vs. 3M passive and during exercise
Treatment:
Device: ContiPressTM
Device: 3M
ContiPress vs. Mobil-O-Graph
Experimental group
Description:
ContiPress vs. Mobil-O-Graph passive, then oscillometric passive, then oscillometric for 24 hrs every 15 mins.
Treatment:
Device: ContiPressTM
Device: Mobil-O-Graph
Device: 3M

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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