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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   Information provided by Assaf-Harofeh Medical Center
First Received: June 17, 2008   Last Updated: June 19, 2008   History of Changes

June 17, 2008
June 19, 2008
August 2008
 
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 ]
Same as current
Complete list of historical versions of study NCT00702286 on ClinicalTrials.gov Archive Site
Renal function improvement [ Time Frame: 28 days per pateint overall 1 year ] [ Designated as safety issue: No ]
Same as current
 
Evaluation of Surface Acoustics Ultrasound Device for the Treatment of Patients With Percutaneous Nephrostomy Catheters
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

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.

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
 
Observational
Ecologic or Community, Prospective
Urinary Tract Infection
 
Two arm, double blinded, comparative, randomized, placebo controlled (active:sham - 2:1) study
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
24
 
 

Inclusion Criteria:

  • Patients requiring percoutaneous nephrostome
  • First insertion

Exclusion Criteria:

  • Blood coagulation disorders
  • Trauma
Both
18 Years and older
No
Contact: Yoram I Siegel, MD 972-8-9779400 yoram.siegel@gmail.com
Israel
 
NCT00702286
Yoram Siegel MD Head of endourolgy unit assaf harofeh MC, Assaf Harofeh MC
75/08
Assaf-Harofeh Medical Center
Nanovibronix
Principal Investigator: Yoram I Siegel, MD Assaf Harofeh MC
Assaf-Harofeh Medical Center
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP