Study Stopped
The investigational devices need alterations before validation
A Novel Non-interfering Arterial Blood Pressure Monitoring Device
1 other identifier
interventional
N/A
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2013
Shorter than P25 for not_applicable hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 29, 2013
CompletedFirst Posted
Study publicly available on registry
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedOctober 1, 2013
September 1, 2013
8 months
May 29, 2013
September 26, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy of measurement
The reference measurements are compared with the measurements made by the investigational device
Up to 4 months
Secondary Outcomes (1)
Skin irritation
Up to 4 months
Study Arms (2)
ContiPress vs. 3M
EXPERIMENTALContiPress vs. 3M passive and during exercise
ContiPress vs. Mobil-O-Graph
EXPERIMENTALContiPress vs. Mobil-O-Graph passive, then oscillometric passive, then oscillometric for 24 hrs every 15 mins.
Interventions
New way of measuring BP - ContiPressTM Investigational device
2 different devices for oscillometric measurement of BP
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sense A/Slead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael H Olsen, Prof. MD
Odense University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2013
First Posted
October 1, 2013
Study Start
April 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
October 1, 2013
Record last verified: 2013-09