Evaluation of Surface Acoustics Ultrasound Device for the Treatment of Patients With Percutaneous Nephrostomy Catheters - Full Text View

Purpose

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.

Condition

Urinary Tract Infection

MedlinePlus related topics:

Ultrasound Urinary Tract Infections

U.S. FDA Resources

Study Type:	Observational
Study Design:	Ecologic or Community, Prospective

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

Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:

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 Measures:

Renal function improvement [ Time Frame: 28 days per pateint overall 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

urine culture

Estimated Enrollment:	24
Study Start Date:	August 2008

Groups/Cohorts

1

Two arm, double blinded, comparative, randomized, placebo controlled (active:sham - 2:1) study

2

Two arm, double blinded, comparative, randomized, placebo controlled (active:sham - 2:1) study

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:

it receives energy and a signal from the UroShield Driver allowing it to generate the ultrasonic waves;
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

All Patients requiring percoutaneous nephrostome drainage for period for more then 4 weeks

Criteria

Inclusion Criteria:

Patients requiring percoutaneous nephrostome
First insertion

Exclusion Criteria:

Blood coagulation disorders
Trauma

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00702286

Contacts


Contact: Yoram I Siegel, MD	972-8-9779400	yoram.siegel@gmail.com

Locations


Israel, Isarel
	Assaf Harofeh MC	Not yet recruiting
	Zerifin, Isarel, Israel, 40700
	Contact: Yoram I Siegel, MD 972-8-9779400 yoram.siegel @gamil.com
	Contact: Amir Peer, MD 972-8-9779483
	Principal Investigator: Yoram I Siegel, MD
	Sub-Investigator: Yenon Roterman, MD
	Sub-Investigator: Amir Copper, MD
	Sub-Investigator: Amir Peer, MD

Sponsors and Collaborators

Assaf-Harofeh Medical Center

Nanovibronix

Investigators


Principal Investigator:	Yoram I Siegel, MD	Assaf Harofeh MC

More Information

Responsible Party:	Assaf Harofeh MC ( Yoram Siegel MD Head of endourolgy unit assaf harofeh MC )
Study ID Numbers:	75/08
First Received:	June 17, 2008
Last Updated:	June 19, 2008
ClinicalTrials.gov Identifier:	NCT00702286
Health Authority:	Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:

Surface acoustic ultrasound

biofilm formation

percoutaneous nephrostomy tube

Patients requiring per coetaneous drainage due to urinary

tract obstruction

To evaluate the efficacy of surface acoustic wave in

reducing pain and improving drainage

Study placed in the following topic categories:

Urologic Diseases

Urinary Tract Infections

Pain

Additional relevant MeSH terms:

Infection

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Assaf-Harofeh Medical Center Nanovibronix
Information provided by:	Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:	NCT00702286