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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Assaf-Harofeh Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Nanovibronix
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT00702286
First received: June 17, 2008
Last updated: June 19, 2008
Last verified: May 2008
  Purpose

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.


Condition
Urinary Tract Infection

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal function improvement [ Time Frame: 28 days per pateint overall 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

urine culture


Estimated Enrollment: 24
Study Start Date: August 2008
Groups/Cohorts
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Patients requiring percoutaneous nephrostome
  • First insertion

Exclusion Criteria:

  • Blood coagulation disorders
  • Trauma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702286

Contacts
Contact: Yoram I Siegel, MD 972-8-9779400 yoram.siegel@gmail.com

Locations
Israel
Assaf Harofeh MC Not yet recruiting
Zerifin, Isarel, Israel, 40700
Contact: Yoram I Siegel, MD    972-8-9779400    yoram.siegel @gamil.com   
Contact: Amir Peer, MD    972-8-9779483      
Principal Investigator: Yoram I Siegel, MD         
Sub-Investigator: Yenon Roterman, MD         
Sub-Investigator: Amir Copper, MD         
Sub-Investigator: Amir Peer, MD         
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Nanovibronix
Investigators
Principal Investigator: Yoram I Siegel, MD Assaf Harofeh MC
  More Information

No publications provided

Responsible Party: Yoram Siegel MD Head of endourolgy unit assaf harofeh MC, Assaf Harofeh MC
ClinicalTrials.gov Identifier: NCT00702286     History of Changes
Other Study ID Numbers: 75/08
Study First Received: June 17, 2008
Last Updated: June 19, 2008
Health Authority: Israel: Ministry of Health

Keywords provided by Assaf-Harofeh Medical Center:
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

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on April 16, 2014