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

NCT ID: NCT00702286

Last Updated: 2008-06-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-08-31

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

Conditions

Urinary Tract Infection

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: PROSPECTIVE

Study Groups

1

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

No interventions assigned to this group

2

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patients requiring percoutaneous nephrostome
• First insertion

Exclusion Criteria

• Blood coagulation disorders
• Trauma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanovibronix

INDUSTRY

Sponsor Role: collaborator

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assaf Harofeh MC

Principal Investigators

Yoram I Siegel, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf Harofeh MC

Locations

Assaf Harofeh MC

Ẕerifin, Isarel, Israel

Countries

Israel

Central Contacts

Yoram I Siegel, MD

Role: CONTACT

yoram.siegel@gmail.com

972-8-9779400

Facility Contacts

Yoram I Siegel, MD

Role: primary

yoram.siegel @gamil.com

972-8-9779400

Amir Peer, MD

Role: backup

972-8-9779483

Other Identifiers

75/08

Identifier Type: -

Identifier Source: org_study_id