|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Assaf-Harofeh Medical Center Nanovibronix |
|---|---|
| Information provided by: | Assaf-Harofeh Medical Center |
| ClinicalTrials.gov Identifier: | NCT00702286 |
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: | Ecologic or Community, 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 |
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
|
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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
All Patients requiring percoutaneous nephrostome drainage for period for more then 4 weeks
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Yoram I Siegel, MD | 972-8-9779400 | yoram.siegel@gmail.com |
| Israel, Isarel | |
| Assaf Harofeh MC | |
| Zerifin, Isarel, Israel, 40700 | |
| Principal Investigator: | Yoram I Siegel, MD | Assaf Harofeh MC |
More Information
| Responsible Party: | Assaf Harofeh MC ( Yoram Siegel MD Head of endourolgy unit assaf harofeh MC ) |
| Study ID Numbers: | 75/08 |
| Study First Received: | June 17, 2008 |
| Last Updated: | June 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00702286 History of Changes |
| Health Authority: | Israel: Ministry of Health |
|
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 |
|
Urologic Diseases Urinary Tract Infections Pain |
|
Urologic Diseases Urinary Tract Infections Infection |