A Novel Non-interfering Arterial Blood Pressure Monitoring Device

Healthy Clinical Trial

Official title:

A Novel Non-interfering Arterial Blood Pressure Monitoring Device

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01954446
• Other study ID #: DK011
• Status: Withdrawn
• Phase: N/A
• First received: May 29, 2013
• Last updated: September 26, 2013
• Start date: April 2013
• Est. completion date: December 2013

Study information

• Verified date: September 2013
• Source: Sense A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Healthy
• Hypertension
• Hypotension

Intervention

Device:
• 3M
Conventional measuring of BP
• ContiPressTM
New way of measuring BP - ContiPressTM Investigational device
• Mobil-O-Graph
2 different devices for oscillometric measurement of BP

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sense A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of measurement	The reference measurements are compared with the measurements made by the investigational device	Up to 4 months	No
Secondary	Skin irritation	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	Yes