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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2009 by Nanovibronix.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Shaare Zedek Medical Center

Information provided by:

Nanovibronix

ClinicalTrials.gov Identifier:

NCT00446732

First received: March 11, 2007

Last updated: March 24, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 11, 2007

Last Updated Date

March 24, 2009

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

primary end points [ Time Frame: up to 14 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

primary end points

Change History

Complete list of historical versions of study NCT00446732 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Catheter Associated Urinary Tract Infections

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Urinary Tract Infection

Intervention ^ICMJE

Device: UroSshield

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

Study Arm (s)

Active Comparator: 1
Intervention: Device: UroSshield
No Intervention: 2

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

June 2009

Estimated Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ofer Shenfeld, MD

972-2-6555560

shenfeld@szmc.org.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT Number ^ICMJE

NCT00446732

Other Study ID Numbers ^ICMJE

US-71-003

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Harold Jacob CEO, NanoVibronix

Study Sponsor ^ICMJE

Nanovibronix

Collaborators ^ICMJE

Shaare Zedek Medical Center

Investigators ^ICMJE

Principal Investigator:

Ofer Shenfeled, MD

Sharei Zedek

Information Provided By

Nanovibronix

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top