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

• Conditions: Urinary Tract Infection

• Registration Number: NCT00702286
• Lead Sponsor: Assaf-Harofeh Medical Center

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 Timeline

• Status Verified: 2008-05
• Study First Submitted: 2008-06-17
• Study First Submitted QC: 2008-06-19
• Last Update Submitted: 2008-06-19
• Study First Posted: 2008-06-20
• Last Update Posted: 2008-06-20
• Study Start: 2008-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Patients requiring percoutaneous nephrostome
• First insertion

Exclusion Criteria

• Blood coagulation disorders
• Trauma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in pain and discomfort in patients with PCN catheters, improvement of catheter's patency.	28 days for one subject overall 1 year

Secondary Outcome Measures

Name	Time	Method
Renal function improvement	28 days per pateint overall 1 year

Trial Locations

Locations (1)

Assaf Harofeh MC; 🇮🇱 Zerifin, Isarel, Israel