Safety and Efficacy of Immages System in Patients Recieving IV Therapy (IV)
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|ClinicalTrials.gov Identifier: NCT02020811|
Recruitment Status : Unknown
Verified May 2013 by PRo-IV.
Recruitment status was: Recruiting
First Posted : December 25, 2013
Last Update Posted : December 25, 2013
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Bacteriemia CHF||Device: Sentinel||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study to Assess the Functionality of Pro-IV's IMMAGES Infusion System in Patients Hospitalized in Bait Balev, Receiving Intravenous Therapy|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||April 2014|
Experimental: sentinel arm
all patients will be recieving Iv therapy by using the sentinel controller, a device that is mounted on the IV administration set.
- 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 ]
- - Detection of medical errors by IMMAGES [ Time Frame: up to 5 minutes from activating the controller on the IV line ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02020811
|Contact: Gizele Sasson, MD||972-52-4425581|
|Contact: michal Devir, MDfirstname.lastname@example.org|
|Bait Balev hospital||Recruiting|
|Bat Yam, Israel|
|Contact: Gisele Sasson, MD 972-52-4425581 email@example.com|
|Principal Investigator: Gisele Sasson, MD|
|Study Chair:||michal devir, MD||PRo-IV|