SepsisIVNCT02020811
Safety and Efficacy of Immages System in Patients Recieving IV Therapy
A study testing Sentinel in people with Sepsis and Bacteriemia, run by PRo-IV at 1 site in Israel.
Trial summary
The study will evaluate the functionality of IMMAGES , an intravenous infusion device system, in patients hospitalized in Bait Balev hospital. The study will aim to determine how the IMMAGES system integrates within IV infusion therapy regime and what are the advantages and disadvantages, if any, of using this system… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Bacteriemia, CHF
- What is being tested?
- Sentinel
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2013to Apr 2014
- 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
- Patients requiring infusion therapy
- Patients receiving infusion therapy by gravity flow or by pump
- patients are scheduled to receive at least once a day an infusion therapy
- Patients are scheduled to receive an infusion therapy for at least 3 days
- Adult over age of 18 years
- Informed consent form signed by patient.
Who cannot join
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- Informed consent form not signed
- Patients are scheduled to receive less than once a day an infusion therapy
- patients to receive less than 3 days of infusion therapy
- patients not hospitalized in a ward that is participating in the study.
- patients participating in another clinical study or clinical field test
- Patients require isolation treatment
Trial locations and contacts
1 site in 1 country.
Gizele Sasson, MD contact
Israel1 site, 1 recruiting
- Recruiting
Bait Balev hospital
Bat Yam
Gisele Sasson, MD, 972-52-4425581, gisele_s@bbalev.co.il
Gisele Sasson, MD
About this study
Official title: A Study to Assess the Functionality of Pro-IV's IMMAGES Infusion System in Patients Hospitalized in Bait Balev, Receiving Intravenous Therapy
The study will evaluate the functionality of IMMAGES , an intravenous infusion device system, in patients hospitalized in Bait Balev hospital. The study will aim to determine how the IMMAGES system integrates within IV infusion therapy regime and what are the advantages and disadvantages, if any, of using this system within the prescribed setting.
Read the detailed description
Using the IMMAGES system in patients recieving IV therapy will provide the nursing teams on-line information regarding the infusions and will allow them to monitor and manage the treatments in real-time, providing better and safer care for the patients.
- Conditions
- Sepsis, Bacteriemia, CHF
- Being tested
- Sentinel
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SentinelDevice
| Study group | Role | What they receive |
|---|---|---|
| sentinel arm | Experimental | all patients will be recieving Iv therapy by using the sentinel controller, a device that is mounted on the IV administration set. Receives: Device: Sentinel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful operation of IMMAGES defined by patient receiving the prescribed IV medication using the IMMAGES system , openning of the controller valve including using the smartphone application and the management software
Measured: as long as the patient is reciving the IV prescribed medication, and no longer than 10 days
Secondary outcomes (1)
- Detection of medical errors by IMMAGES
If there is an error related to administration of wrong drug. to the wrong patient , on the wrong timing - the valve of the controller will not open , and the IV line will stay closed, and the patient will not get the wrong drug.
Measured: up to 5 minutes from activating the controller on the IV line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PRo-IV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bait Balev Hospital
- Responsible party
- Sponsor
- Investigators
- michal devir, MD, Study chair, PRo-IV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020811
- Sponsor's protocol ID
- BBALEV-1
- Acronym
- IV
- Status last verified
- May 2013
- First submitted
- 19 Dec 2013
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Functionality of Pro-IV's IMMAGES Infusion System in Patients Hospitalized in Bait Balev, Receiving Intravenous Therapy
- ClinicalTrials.gov ID
- NCT02020811
- Acronym / sponsor ID
- IV / BBALEV-1
- Conditions
- Sepsis, Bacteriemia, CHF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- PRo-IVIndustry (pharma, biotech, devices)
- Collaborators
- Bait Balev Hospital
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 25 Dec 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 study will evaluate the functionality of IMMAGES , an intravenous infusion device system, in patients hospitalized in Bait Balev hospital. The study will aim to determine how the IMMAGES system integrates within IV infusion therapy regime and what are the advantages and disadvantages, if any, of using this system within the prescribed setting.
Detailed description
Using the IMMAGES system in patients recieving IV therapy will provide the nursing teams on-line information regarding the infusions and will allow them to monitor and manage the treatments in real-time, providing better and safer care for the patients.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sentinel arm | Experimental | Device: Sentinelall patients will be recieving Iv therapy by using the sentinel controller, a device that is mounted on the IV administration set. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (7 listed)
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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 |
|---|---|---|
| Sentinel | Device | sentinel arm |
Primary outcome
Successful operation of IMMAGES defined by patient receiving the prescribed IV medication using the IMMAGES system , openning of the controller valve including using the smartphone application and the management software
Time frame: as long as the patient is reciving the IV prescribed medication, and no longer than 10 days
1 secondary outcome
- Detection of medical errors by IMMAGES
Time frame: up to 5 minutes from activating the controller on the IV line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
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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.
Gizele Sasson, MD contact
michal devir, MD study chair
PRo-IV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel in people with Sepsis and Bacteriemia, run by PRo-IV 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 6 inclusion and 7 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 25 Dec 2013. 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 Gizele Sasson, MD (972-52-4425581), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful operation of IMMAGES defined by patient receiving the prescribed IV medication using the IMMAGES system , openning of the controller valve including using the smartphone application and the management software (time frame: as long as the patient is reciving the IV prescribed medication, and no longer than 10 days). 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 25 Dec 2013.