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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02020811
Other study ID # BBALEV-1
Secondary ID
Status Recruiting
Phase N/A
First received December 19, 2013
Last updated December 19, 2013
Start date November 2013
Est. completion date April 2014

Study information

Verified date May 2013
Source PRo-IV
Contact Gizele Sasson, MD
Phone 972-52-4425581
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical 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 within the prescribed setting.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Inclusion criteria:

1. Patients requiring infusion therapy

2. Patients receiving infusion therapy by gravity flow or by pump

3. patients are scheduled to receive at least once a day an infusion therapy

4. Patients are scheduled to receive an infusion therapy for at least 3 days

5. Adult over age of 18 years

6. Informed consent form signed by patient.

Exclusion Criteria:

1. Informed consent form not signed

2. Patients are scheduled to receive less than once a day an infusion therapy

3. patients to receive less than 3 days of infusion therapy

4. patients not hospitalized in a ward that is participating in the study.

5. patients participating in another clinical study or clinical field test

6. Patients require isolation treatment

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Device:
Sentinel


Locations

Country Name City State
Israel Bait Balev hospital Bat Yam

Sponsors (2)

Lead Sponsor Collaborator
PRo-IV Bait Balev Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary - 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. up to 5 minutes from activating the controller on the IV line Yes
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