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

March 11, 2007
March 24, 2009
March 2007
April 2009   (final data collection date for primary outcome measure)
primary end points [ Time Frame: up to 14 days ] [ Designated as safety issue: Yes ]
primary end points
Complete list of historical versions of study NCT00446732 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Use of the UroShield Device in Patients With Indwelling Urinary Catheters
Catheter Associated Urinary Tract Infections

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.

This study is aimed at assessing the effectiveness of the NanoVibronix™ UroShield™ System in comparison to Urinary catheter alone in patients requiring urinary catheterization.

  1. 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
  2. Safety Objective To assess the safety parameters of the UroShield system
  3. 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
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Urinary Tract Infection
Device: UroSshield
Attachment of the UroShield device to the external part of the urinary catheter
  • Active Comparator: 1
    Intervention: Device: UroSshield
  • No Intervention: 2
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
June 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ofer Shenfeld, MD 972-2-6555560 shenfeld@szmc.org.il
Israel
 
NCT00446732
US-71-003
Yes
Dr. Harold Jacob CEO, NanoVibronix
Nanovibronix
Shaare Zedek Medical Center
Principal Investigator: Ofer Shenfeled, MD Sharei Zedek
Nanovibronix
March 2009

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