Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT00446732
Status:
UNKNOWN
Last Update Posted:
2009-03-25
First Post:
2007-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Use of the UroShield Device in Patients With Indwelling Urinary Catheters
Sponsor:
Nanovibronix
Organization:
Study Overview
Official Title:
Catheter Associated Urinary Tract Infections
Status:
UNKNOWN
Status Verified Date:
2009-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAUTI
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 compare standard treatment (urinary catheter alone) with the UroShield treatment in occurrence of catheter associated Urinary Tract infection, pain, discomfort, Biofilm prevention and trauma.
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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: