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

NCT ID: NCT00702286

Last Updated: 2008-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Brief Summary

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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

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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

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Urinary Tract Infection

Keywords

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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 Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

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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

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Nanovibronix

INDUSTRY

Sponsor Role collaborator

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf Harofeh MC

Principal Investigators

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Yoram I Siegel, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf Harofeh MC

Locations

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Assaf Harofeh MC

Ẕerifin, Isarel, Israel

Site Status

Countries

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Israel

Central Contacts

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Yoram I Siegel, MD

Role: CONTACT

Phone: 972-8-9779400

Email: [email protected]

Facility Contacts

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Yoram I Siegel, MD

Role: primary

Amir Peer, MD

Role: backup

Other Identifiers

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75/08

Identifier Type: -

Identifier Source: org_study_id