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Evaluation of Surface Acoustics Ultrasound Device for the Treatment of Patients With Percutaneous Nephrostomy Catheters (NV-US-04-001)

This study is not yet open for participant recruitment.
Study NCT00702286.   Last updated on June 19, 2008.   Information provided by Assaf-Harofeh Medical Center

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Descriptive Information Fields
Brief Title  Evaluation of Surface Acoustics Ultrasound Device for the Treatment of Patients With Percutaneous Nephrostomy Catheters
Official Title  Phase II Prospective Comparison Randomized Placebo Controlled Double Blind Study to Evaluate the Efficacy of the UroShieldTM Surface Acoustics Ultrasound Device for the Treatment of Patients With Percutaneous Nephrostomy
Brief Summary

Catheter associated urinary tract infection is one of the most common types of catheter acquired infections and adds greatly to patient morbidity, mortality and medical cost. Urinary catheters may readily acquire biofilms when inserted. The longer the catheter remains in place, the greater the tendency of these organisms to develop biofilms and result in urinary tract infections, which are difficult to treathe UroShield System is intended to prevent bacterial biofilm formation by means of the Active NanoShield technology it has developed. A number of scientific concepts and principles shown in prior studies have shown some promising results in the treatment of biofilm based sequele using ultrasound energy. The NanoShield technological basis of the UroShield System has taken these concepts to a level where acoustical waves in the ultrasound range can be created by low cost disposable actuators which actually create a physical coating on all of the surfaces of the catheter thereby interfering with the attachment of bacteria which is the initial step in biofilm formation.

Detailed Description

The UroShield™ System is comprised of 2 main components:· The Disposable UroShield Z-Patch - a disposable small lightweight patch that is attached to the PCN catheter, while its opposite side is attached directly to the patient's skin at the site of catheter entry. The patch has twofold function:

  1. it receives energy and a signal from the UroShield Driver allowing it to generate the ultrasonic waves;
  2. it acts as a fixation device for the PCN catheter.· The UroShield Driver - an external driver unit that is attached to the UroShield patch and contains batteries to power the system and electronics that control the patch unit
Study Phase
Study Type  Observational
Study Design  Ecologic or Community, Prospective
Primary Outcome Measure  Reduction in pain and discomfort in patients with PCN catheters, improvement of catheter's patency. [ Time Frame: 28 days for one subject overall 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Renal function improvement [ Time Frame: 28 days per pateint overall 1 year ] [ Designated as safety issue: No ]
Condition  Urinary Tract Infection
Intervention 
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Not yet recruiting
Enrollment  24
Start Date  August 2008
Completion Date
Eligibility Criteria 

Inclusion Criteria:

  • Patients requiring percoutaneous nephrostome
  • First insertion

Exclusion Criteria:

  • Blood coagulation disorders
  • Trauma
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Contact: Yoram I Siegel, MD     972-8-9779400     yoram.siegel@gmail.com    
Location Countries  Israel
Administrative Information Fields
NCT ID  NCT00702286
Organization ID 75/08
Secondary IDs ††
Study Sponsor  Assaf-Harofeh Medical Center
Collaborators †† Nanovibronix
Investigators 
Principal Investigator:     Yoram I Siegel, MD     Assaf Harofeh MC    
Information Provided By Assaf-Harofeh Medical Center
Verification Date May 2008
First Received Date  June 17, 2008
Last Updated Date June 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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