Blood Pressure (Low, Normal, High)SNIPENCT01482325
SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement
A study testing Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor in people with Blood Pressure (Low, Normal, High), run by GE Healthcare at 2 sites in United States.
Trial summary
The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure (Low, Normal, High)
- What is being tested?
- Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
- Ability of a minor subject ages 7 to 18 to provide written assent
- Ability to have multiple noninvasive blood pressures taken at one sitting
- Ability to apply three lead ECG, if needed for investigation
- Ability to detect the natural presence of an irregular pulse, for irregular pulse studies
Who cannot join
- Any subject who cannot tolerate multiple blood pressure measurements
- Any subject who cannot undergo 3-lead ECG, if needed
- Any subject deemed unstable by the principal investigator
- Any subject for whom precautions are necessary because of communicable disease
- Any subject that has a known disease or condition compromises musculoskeletal integrity
- Any subject that has a known disease or condition that contraindicates use of an NIBP cuff and ECG patches on the skin.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Josephs Hospital
Milwaukee, Wisconsin, 53210
Wisconsin Heart Hospital
Wauwatosa, Wisconsin, 53226
About this study
Official title: SNIPE:SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement
The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements.
- Conditions
- Blood Pressure (Low, Normal, High)
- Being tested
- Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure monitoring with GE Healthcare DASH2500 Patient MonitorDevice
10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor
| Study group | Role | What they receive |
|---|---|---|
| Subjects requiring blood pressure monitoring | Experimental | Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring Receives: Device: Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection for Engineering Development
This was a data collection for engineering development to demonstrate SuperSTAT 2.0 NIBP software algorithm meets the engineering specifications. Engineers reviewed data produced by each blood pressure determination to work on new software algorithm in development. This was not conducted as program was terminated prematurely.
Software iterations are not pre-defined.
Measured: After each iteration of software development
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: The business decided not to pursue the study at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Blood Pressure (Low, Normal, High)Studies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482325
- Sponsor's protocol ID
- 118.02-2011-GES-0002
- Acronym
- SNIPE
- Status last verified
- Aug 2016
- First submitted
- 28 Nov 2011
- Last updated
- 30 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SNIPE:SuperSTAT 2.0 Noninvasive Blood Pressure Algorithm Enhancement
- ClinicalTrials.gov ID
- NCT01482325
- Acronym / sponsor ID
- SNIPE / 118.02-2011-GES-0002
- Conditions
- Blood Pressure (Low, Normal, High)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The business decided not to pursue the study at this time.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Nov 2011 (estimated)
- Results
- Posted 30 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to show that the noninvasive blood pressure software algorithm meets engineering requirements.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects requiring blood pressure monitoring | Experimental | Device: Blood pressure monitoring with GE Healthcare DASH2500 Patient MonitorAny subject (neonate-adult) requiring hospital or clinic blood pressure monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide written informed consent or have a legally authorized representative including a parent or guardian provide written informed consent
- Ability of a minor subject ages 7 to 18 to provide written assent
- Ability to have multiple noninvasive blood pressures taken at one sitting
- Ability to apply three lead ECG, if needed for investigation
- Ability to detect the natural presence of an irregular pulse, for irregular pulse studies
Key exclusion criteria (6 listed)
- Any subject who cannot tolerate multiple blood pressure measurements
- Any subject who cannot undergo 3-lead ECG, if needed
- Any subject deemed unstable by the principal investigator
- Any subject for whom precautions are necessary because of communicable disease
- Any subject that has a known disease or condition compromises musculoskeletal integrity
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 monitoring with GE Healthcare DASH2500 Patient Monitor10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor | Device | Subjects requiring blood pressure monitoring |
Primary outcome
Data Collection for Engineering Development
Time frame: After each iteration of software development
This was a data collection for engineering development to demonstrate SuperSTAT 2.0 NIBP software algorithm meets the engineering specifications. Engineers reviewed data produced by each blood pressure determination to work on new software algorithm in development. This was not conducted as program was terminated prematurely. Software iterations are not pre-defined.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor in people with Blood Pressure (Low, Normal, High), run by GE Healthcare at 2 sites 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 5 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: stopped early, as of the sponsor's last update on 30 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 30 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Data Collection for Engineering Development (time frame: After each iteration of software development). 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 30 Sep 2016.