Evaluation of Surface Acoustics Ultrasound Device for the Treatment of Patients With Percutaneous Nephrostomy Catheters

Urinary Tract Infection Clinical Trial

— NV-US-04-001  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00702286
• Other study ID #: 75/08
• Status: Not yet recruiting
• Phase: N/A
• First received: June 17, 2008
• Last updated: June 19, 2008
• Start date: August 2008

Study information

• Verified date: May 2008
• Source: Assaf-Harofeh Medical Center
• Contact: Yoram I Siegel, MD
• Phone: 972-8-9779400
• Email: yoram.siegel[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients requiring percoutaneous nephrostome

• First insertion

Exclusion Criteria:

• Blood coagulation disorders

• Trauma

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Urinary Tract Infection
• Urinary Tract Infections

Locations

Country	Name	City	State
Israel	Assaf Harofeh MC	Zerifin	Isarel

Sponsors (2)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center	Nanovibronix

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in pain and discomfort in patients with PCN catheters, improvement of catheter's patency.		28 days for one subject overall 1 year	No
Secondary	Renal function improvement		28 days per pateint overall 1 year	No