HypertensionNCT00944983
Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children
An observational study of Hypertension, run by Tiba Medical, Inc. at 1 site in United States.
Trial summary
Clinical validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitoring system according to the accuracy guidelines of the ISO 80601-2-30 Standard in Adults, Adolescents, and Children. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2009
- Phase
- Observational
- 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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Adults, Adolescents, and Children of different genders, ages, races \& sizes (height, weight \& particularly arm size) plus blood pressure ranges (normatensive, hypotensive and hypertensive).
Who may be able to join
- Ages > 3 Years Old
Who cannot join
- Severe Arrhythmia
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Medical Group
Memphis, Tennessee, 38105
About this study
Clinical validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitoring system according to the accuracy guidelines of the ISO 80601-2-30 Standard in Adults, Adolescents, and Children.
- Conditions
- Hypertension
- Keywords
- Hypertension, Hypotension, Clinical Validation, Blood Pressure Accuracy, ISO 81600 Standard, British Hypertension Society, European Society of Hypertension, International Protocol
- Medical subject headings
- Hypertension, Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
Series of blood pressure measurements obtained in 100+ subjects
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2009
- Study completionDec 2009
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
- Observational
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiba Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Tennessee
- Responsible party
- Sponsor
- Investigators
- Bruce Alpert, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00944983
- Sponsor's protocol ID
- UT09-00420-XP
- Status last verified
- May 2014
- First submitted
- 21 Jul 2009
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of the Tiba Medical Ambulo 2400 ABPM According to the ISO 80601-2-30 Standard in Adults, Adolescents, and Children
- ClinicalTrials.gov ID
- NCT00944983
- Acronym / sponsor ID
- UT09-00420-XP
- Conditions
- Hypertension
- Keywords
- Hypertension, Hypotension, Clinical Validation, Blood Pressure Accuracy, ISO 81600 Standard, British Hypertension Society, European Society of Hypertension, International Protocol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Tiba Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Tennessee
- Study start
- Jul 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Jul 2009 (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.
Clinical validation of the Tiba Medical Ambulo 2400 ambulatory blood pressure monitoring system according to the accuracy guidelines of the ISO 80601-2-30 Standard in Adults, Adolescents, and Children.
Study design
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults, Adolescents, and Children of different genders, ages, races \& sizes (height, weight \& particularly arm size) plus blood pressure ranges (normatensive, hypotensive and hypertensive).
Key inclusion criteria (1 listed)
- Ages > 3 Years Old
Key exclusion criteria (1 listed)
- Severe Arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Series of blood pressure measurements obtained in 100+ subjects
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- ISO 80601-2-30 StandardLink provided by the sponsor.
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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.
Bruce Alpert, MD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Tiba Medical, Inc. at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 7 May 2014. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Series of blood pressure measurements obtained in 100+ subjects (time frame: 2 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 7 May 2014.