HypertensionNCT00265707
Evaluation of a New Blood Pressure Measuring Device.
A study testing Blood pressure measurement in people with Hypertension, run by Maaynei Hayesha Medical Center at 1 site in Israel.
Trial summary
A disposable blood pressure measuring device will be tested and compared to a standard mercury sphygmomanometer. Up to 100 subjects with various levels of blood pressure values will be tested. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Blood pressure measurement
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2005to Dec 2005
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age 18 years or above
- Signed written informed consent
Who cannot join
- A history of cardiac arrythmia
- Wrist circumference smaller than 13cm or larger than 19.5cm
- Documented peripheral vascular disease
- Damage or injury to the left wrist
- Participation in any other clinical study
- Any acute coronary of cardiovascular illness
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Department of Medicine, Maaynei Hayesha Hospital
Tel Aviv, 51544
Itzhak Klinger, MD, 972-3-5771216, klinger@mhmc.co.il
Mordchai Ravid, MD FACP
About this study
Official title: A Study to Evaluate the Safety and Effectiveness (Overall Performance) of the Press-O-Sense Non-Invasive Blood Pressure Measuring Device.
- A disposable blood pressure measuring device will be tested and compared to a standard mercury sphygmomanometer.
- Up to 100 subjects with various levels of blood pressure values will be tested.
Read the detailed description
The study will comprise 85 to 100 subjects with blood pressure values ranging between 90 and 170mmHg -systolic and 65-95 -diastolic.
- Three sets of measurements will be performed on each subject. The measurement with the tested device placed between twh determinations with a mercury sphygmomanometer.
- Each measurement will be performed simultaneously by two examiners specially trained.
- Informed consent will be obtained from all participants.
- The results will be evaluated by a standard statistical plan ANSI/AAMI SP-10 2002.
- Conditions
- Hypertension
- Being tested
- Blood pressure measurement
- Keywords
- Hypertension, Hypotension
- Medical subject headings
- Hypertension, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure measurementDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the paired measurements with the tested device and the reference measurements (with a mercury sphygmomanometer) will differ by no more than +-5mmHg.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
- Study startSep 2005
- Study completionDec 2005
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Maaynei Hayesha Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Mordchai Ravid, MD FACP, Principal investigator, Maaynei Hayesha Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265707
- Sponsor's protocol ID
- DPTYN001CTIL
- Status last verified
- Dec 2005
- First submitted
- 14 Dec 2005
- Last updated
- 9 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Safety and Effectiveness (Overall Performance) of the Press-O-Sense Non-Invasive Blood Pressure Measuring Device.
- ClinicalTrials.gov ID
- NCT00265707
- Acronym / sponsor ID
- DPTYN001CTIL
- Conditions
- Hypertension
- Keywords
- Hypertension, Hypotension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- Maaynei Hayesha Medical CenterUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Dec 2005
- First posted
- 15 Dec 2005 (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.
- A disposable blood pressure measuring device will be tested and compared to a standard mercury sphygmomanometer.
- Up to 100 subjects with various levels of blood pressure values will be tested.
Detailed description
The study will comprise 85 to 100 subjects with blood pressure values ranging between 90 and 170mmHg -systolic and 65-95 -diastolic.
- Three sets of measurements will be performed on each subject. The measurement with the tested device placed between twh determinations with a mercury sphygmomanometer.
- Each measurement will be performed simultaneously by two examiners specially trained.
- Informed consent will be obtained from all participants.
- The results will be evaluated by a standard statistical plan ANSI/AAMI SP-10 2002.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female, age 18 years or above
- Signed written informed consent
Key exclusion criteria (6 listed)
- A history of cardiac arrythmia
- Wrist circumference smaller than 13cm or larger than 19.5cm
- Documented peripheral vascular disease
- Damage or injury to the left wrist
- Participation in any other clinical study
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 |
|---|---|---|
| Blood pressure measurement | Device | – |
Primary outcome
The difference between the paired measurements with the tested device and the reference measurements (with a mercury sphygmomanometer) will differ by no more than +-5mmHg.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2006.
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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.
Mordchai Ravid, MD FACP principal investigator
Maaynei Hayesha Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure measurement in people with Hypertension, run by Maaynei Hayesha Medical Center at 1 site in Israel.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 9 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mordchai Ravid, MD FACP (972-3-5771113, ravid@mhmc.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference between the paired measurements with the tested device and the reference measurements (with a mercury sphygmomanometer) will differ by no more than +-5mmHg.. 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 9 Oct 2006.