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
  Purpose

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.


Condition Intervention Phase
Urinary Tract Infection
Device: UroSshield
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Catheter Associated Urinary Tract Infections

Resource links provided by NLM:


Further study details as provided by Nanovibronix:

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

Estimated Enrollment: 200
Study Start Date: March 2007
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Device: UroSshield
Attachment of the UroShield device to the external part of the urinary catheter
No Intervention: 2

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.

  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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446732

Contacts
Contact: Ofer Shenfeld, MD 972-2-6555560 shenfeld@szmc.org.il

Locations
Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel
Contact: Ofer Shenfeld, MD         
Sponsors and Collaborators
Nanovibronix
Shaare Zedek Medical Center
Investigators
Principal Investigator: Ofer Shenfeled, MD Sharei Zedek
  More Information

No publications provided

Responsible Party: Dr. Harold Jacob CEO, NanoVibronix
ClinicalTrials.gov Identifier: NCT00446732     History of Changes
Other Study ID Numbers: US-71-003
Study First Received: March 11, 2007
Last Updated: March 24, 2009
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Communicable Diseases
Infection
Urinary Tract Infections
Urologic Diseases

ClinicalTrials.gov processed this record on October 22, 2014