Safety and Efficacy of Immages System in Patients Recieving IV Therapy
IV
A Study to Assess the Functionality of Pro-IV's IMMAGES Infusion System in Patients Hospitalized in Bait Balev, Receiving Intravenous Therapy
1 other identifier
interventional
50
1 country
1
Brief 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 within the prescribed setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable sepsis
Started Nov 2013
Shorter than P25 for not_applicable sepsis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 19, 2013
CompletedFirst Posted
Study publicly available on registry
December 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedDecember 25, 2013
May 1, 2013
5 months
December 19, 2013
December 19, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
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
up to 5 minutes from activating the controller on the IV line
Study Arms (1)
sentinel arm
EXPERIMENTALall patients will be recieving Iv therapy by using the sentinel controller, a device that is mounted on the IV administration set.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
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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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PRo-IVlead
- Bait Balev Hospitalcollaborator
Study Sites (1)
Bait Balev hospital
Bat Yam, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
michal devir, MD
PRo-IV
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2013
First Posted
December 25, 2013
Study Start
November 1, 2013
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
December 25, 2013
Record last verified: 2013-05