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The Use of the UroShield Device in Patients With Indwelling Urinary Catheters (CAUTI)

Primary Purpose

Urinary Tract Infection

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

UroSshield

About this trial

This is an interventional prevention trial for Urinary Tract Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Hospitalized patients age 18 years or older
Patients requiring or having catheterization for more than 24 hours
Patient able, agrees and signs the Informed Consent Form

Exclusion Criteria:

Pregnant or breastfeeding women. Women of child bearing potential will perform a pregnancy test before inclusion into the study
Presence of any clinically relevant known urinary tract infection
Patient with condition who is not expected to survive the study period
Known HIV positive
Patient has any condition, which precludes compliance with study and/or device instructions.
Patient is currently participating in another clinical study.
Known allergy to latex

Sites / Locations

Shaare Zedek Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

primary end points

Secondary Outcome Measures

Full Information

NCT ID

NCT00446732

First Posted

March 11, 2007

Last Updated

March 24, 2009

Sponsor

Nanovibronix

Collaborators

Shaare Zedek Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00446732

Brief Title

The Use of the UroShield Device in Patients With Indwelling Urinary Catheters

Acronym

CAUTI

Official Title

Catheter Associated Urinary Tract Infections

Study Type

Interventional

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

March 2007 (undefined)

Primary Completion Date

April 2009 (Anticipated)

Study Completion Date

June 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Nanovibronix

Collaborators

Shaare Zedek Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

According to the Israeli Ministry of Health requirement, this study was designed to evaluate the efficacy of the UroShield system is patients that require urinary catheterization. This was designed to compare standard treatment (urinary catheter alone) with the UroShield treatment in occurrence of catheter associated Urinary Tract infection, pain, discomfort, Biofilm prevention and trauma.

Detailed Description

This study is aimed at assessing the effectiveness of the NanoVibronix™ UroShield™ System in comparison to Urinary catheter alone in patients requiring urinary catheterization. Primary objectives To observe the effect of UroShield in reduction of patient's complaints relating to indwelling Urinary Catheters Pain Discomfort To observe the effect of UroShield in the reduction/prevention of Biofilm To observe the effect of UroShield on the occurrence of bacteriuria and/or UTI's on patients with Indwelling Urinary Catheters Safety Objective To assess the safety parameters of the UroShield system Secondary Objectives To observe the effect of UroShield in reduction of Foley Catheter related pain medication in patients with Indwelling Urinary Catheters To observe the effect of UroShield in reduction of antibiotic medication in patients with Indwelling Urinary Catheter To observe the effect of UroShield on the clogging of Urinary Catheter when used chronically and the need to replace the catheter To observe the effect of UroShield on the decrease of Tissue damage of patients with Indwelling Urinary Catheters by measuring cell count before and after removal of catheter

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

UroSshield

Intervention Description

Attachment of the UroShield device to the external part of the urinary catheter

Primary Outcome Measure Information:

Title

primary end points

Time Frame

up to 14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hospitalized patients age 18 years or older Patients requiring or having catheterization for more than 24 hours Patient able, agrees and signs the Informed Consent Form Exclusion Criteria: Pregnant or breastfeeding women. Women of child bearing potential will perform a pregnancy test before inclusion into the study Presence of any clinically relevant known urinary tract infection Patient with condition who is not expected to survive the study period Known HIV positive Patient has any condition, which precludes compliance with study and/or device instructions. Patient is currently participating in another clinical study. Known allergy to latex

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ofer Shenfeld, MD

Phone

972-2-6555560

shenfeld@szmc.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ofer Shenfeled, MD

Organizational Affiliation

Sharei Zedek

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shaare Zedek Medical Center

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ofer Shenfeld, MD

12. IPD Sharing Statement

Learn more about this trial

The Use of the UroShield Device in Patients With Indwelling Urinary Catheters

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