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| Name | Class |
|---|---|
| Nanovibronix | INDUSTRY |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Reduction in pain and discomfort in patients with PCN catheters, improvement of catheter's patency. | 28 days for one subject overall 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function improvement | 28 days per pateint overall 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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All Patients requiring percoutaneous nephrostome drainage for period for more then 4 weeks
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yoram I Siegel, MD | Contact | 972-8-9779400 | yoram.siegel@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yoram I Siegel, MD | Assaf Harofeh MC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofeh MC | Ẕerifin | Isarel | 40700 | Israel |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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urine culture
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |