The Use of the UroShield Device in Patients With Indwelling Urinary Catheters
NCT ID: NCT00446732
Last Updated: 2009-03-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2007-03-31
2009-06-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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1
UroSshield
Attachment of the UroShield device to the external part of the urinary catheter
2
No interventions assigned to this group
Interventions
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UroSshield
Attachment of the UroShield device to the external part of the urinary catheter
Eligibility Criteria
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Inclusion Criteria
* Patients requiring or having catheterization for more than 24 hours
* Patient able, agrees and signs the Informed Consent Form
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Shaare Zedek Medical Center
OTHER
Nanovibronix
INDUSTRY
Responsible Party
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NanoVibronix
Principal Investigators
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Ofer Shenfeled, MD
Role: PRINCIPAL_INVESTIGATOR
Sharei Zedek
Locations
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Shaare Zedek Medical Center
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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Ofer Shenfeld, MD
Role: primary
Other Identifiers
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US-71-003
Identifier Type: -
Identifier Source: org_study_id
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