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

June 19, 2008 updated by: Assaf-Harofeh Medical Center

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.

Study Overview

Status

Unknown

Conditions

Urinary Tract Infection

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

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- Isarel
  - Zerifin, Isarel, Israel, 40700
    - Assaf Harofeh MC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

Patients requiring percoutaneous nephrostome
First insertion

Exclusion Criteria:

Blood coagulation disorders
Trauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	28 days for one subject overall 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Renal function improvement Time Frame: 28 days per pateint overall 1 year	28 days per pateint overall 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Collaborators

Nanovibronix

Investigators

Principal Investigator: Yoram I Siegel, MD, Assaf Harofeh MC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 19, 2008

First Posted (Estimate)

June 20, 2008

Study Record Updates

Last Update Posted (Estimate)