Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00702286
Acronym
NV-US-04-001
Enrollment
24
Registered
2008-06-20
Start date
2008-08-31
Completion date
Unknown
Last updated
2008-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Tract Infection

Keywords

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

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

Interventions

None listed

Sponsors

Nanovibronix
CollaboratorINDUSTRY
Assaf-Harofeh Medical Center
Lead SponsorOTHER_GOV

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients requiring percoutaneous nephrostome * First insertion

Exclusion criteria

* Blood coagulation disorders * Trauma

Design outcomes

Primary

MeasureTime frame
Reduction in pain and discomfort in patients with PCN catheters, improvement of catheter's patency.28 days for one subject overall 1 year

Secondary

MeasureTime frame
Renal function improvement28 days per pateint overall 1 year

Countries

Israel

Contacts

Primary ContactYoram I Siegel, MD
yoram.siegel@gmail.com972-8-9779400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026