Status:
UNKNOWN
The Use of the UroShield Device in Patients With Indwelling Urinary Catheters
Lead Sponsor:
Nanovibronix
Collaborating Sponsors:
Shaare Zedek Medical Center
Conditions:
Urinary Tract Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00446732
Start Date
March 1 2007
End Date
June 1 2009
Last Update
March 25 2009
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel