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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00446732
Other study ID # US-71-003
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received March 11, 2007
Last updated March 24, 2009
Start date March 2007
Est. completion date June 2009

Study information

Verified date March 2009
Source Nanovibronix
Contact Ofer Shenfeld, MD
Phone 972-2-6555560
Email shenfeld@szmc.org.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 2009
Est. primary completion date April 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
UroSshield
Attachment of the UroShield device to the external part of the urinary catheter

Locations

Country Name City State
Israel Shaare Zedek Medical Center Jerusalem

Sponsors (2)

Lead Sponsor Collaborator
Nanovibronix Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary primary end points up to 14 days Yes
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