HypertensionNCT01954446
A Novel Non-interfering Arterial Blood Pressure Monitoring Device
A study testing 3M, ContiPressTM and Mobil-O-Graph in people with Hypertension and Hypotension, run by Sense A/S.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Hypotension, Healthy
- What is being tested?
- 3M, ContiPressTM and Mobil-O-Graph
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Breached skin
- Acknowledged pregnancy
- Pacemaker
- Diagnosed cardiac arrhythmia (tachycardia, bradycardia, atrial/ventricular fibrillation)
- Implanted metal in upper limb:
- Elbow prosthesis
Show all 18Show fewer
- 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
About this study
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).
Read the 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.
- Conditions
- Hypertension, Hypotension, Healthy
- Being tested
- 3M, ContiPressTM, Mobil-O-Graph
- Medical subject headings
- Hypertension, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3MDevice
Conventional measuring of BP
ContiPressTMDevice
New way of measuring BP - ContiPressTM
Investigational device
Mobil-O-GraphDevice
2 different devices for oscillometric measurement of BP
| Study group | Role | What they receive |
|---|---|---|
| ContiPress vs. 3M | Experimental | ContiPress vs. 3M passive and during exercise Receives: Device: 3M; Device: ContiPressTM |
| ContiPress vs. Mobil-O-Graph | Experimental | ContiPress vs. Mobil-O-Graph passive, then oscillometric passive, then oscillometric for 24 hrs every 15 mins. Receives: Device: 3M; Device: ContiPressTM; Device: Mobil-O-Graph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of measurement
The reference measurements are compared with the measurements made by the investigational device
Measured: Up to 4 months
Secondary outcomes (1)
Skin irritation
After removal of each investigational device the skin is assessed. Also participants are instructed to report any skin irritation to investigator
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Why it stopped: The investigational devices need alterations before validation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sense A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael H Olsen, Prof. MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954446
- Sponsor's protocol ID
- DK011
- Status last verified
- Sep 2013
- First submitted
- 29 May 2013
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Non-interfering Arterial Blood Pressure Monitoring Device
- ClinicalTrials.gov ID
- NCT01954446
- Acronym / sponsor ID
- DK011
- Conditions
- Hypertension, Hypotension, Healthy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigational devices need alterations before validation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sense A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ContiPress vs. 3M | Experimental | Device: 3M, Device: ContiPressTMContiPress vs. 3M passive and during exercise |
| ContiPress vs. Mobil-O-Graph | Experimental | Device: 3M, Device: ContiPressTM, Device: Mobil-O-GraphContiPress vs. Mobil-O-Graph passive, then oscillometric passive, then oscillometric for 24 hrs every 15 mins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (18 listed)
- Breached skin
- Acknowledged pregnancy
- Pacemaker
- Diagnosed cardiac arrhythmia (tachycardia, bradycardia, atrial/ventricular fibrillation)
- Implanted metal in upper limb:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3MConventional measuring of BP | Device | ContiPress vs. 3M, ContiPress vs. Mobil-O-Graph |
| ContiPressTMNew way of measuring BP - ContiPressTM Investigational device | Device | ContiPress vs. 3M, ContiPress vs. Mobil-O-Graph |
| Mobil-O-Graph2 different devices for oscillometric measurement of BP | Device | ContiPress vs. Mobil-O-Graph |
Primary outcome
Accuracy of measurement
Time frame: Up to 4 months
The reference measurements are compared with the measurements made by the investigational device
1 secondary outcome
Skin irritation
Time frame: Up to 4 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2013.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Olsen, Prof. MD principal investigator
Odense University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing 3M, ContiPressTM and Mobil-O-Graph in people with Hypertension and Hypotension, run by Sense A/S.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of measurement (time frame: Up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2013.