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Safety and Efficacy of Immages System in Patients Recieving IV Therapy

NCT ID: NCT02020811

Last Updated: 2013-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-04-30

Brief Summary

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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

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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

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Sepsis Bacteriemia CHF

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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sentinel arm

all patients will be recieving Iv therapy by using the sentinel controller, a device that is mounted on the IV administration set.

Group Type EXPERIMENTAL

Sentinel

Intervention Type DEVICE

Interventions

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Sentinel

Intervention Type DEVICE

Eligibility Criteria

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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

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bait Balev Hospital

OTHER

Sponsor Role collaborator

PRo-IV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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michal devir, MD

Role: STUDY_CHAIR

PRo-IV

Locations

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Bait Balev hospital

Bat Yam, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Gizele Sasson, MD

Role: CONTACT

Phone: 972-52-4425581

michal Devir, MD

Role: CONTACT

Phone: 972-9-8664128

Email: [email protected]

Facility Contacts

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Gisele Sasson, MD

Role: primary

Other Identifiers

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BBALEV-1

Identifier Type: -

Identifier Source: org_study_id