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

NCT00702286 | Unknown

• 1 other identifier: 75/08
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Reduction in pain and discomfort in patients with PCN catheters, improvement of catheter's patency.

  28 days for one subject overall 1 year

Secondary Outcomes (1)

• Renal function improvement

  28 days per pateint overall 1 year

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients requiring percoutaneous nephrostome
• First insertion

You may not qualify if:

• Blood coagulation disorders
• Trauma

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead
• Nanovibronix: collaborator

Study Sites (1)

Assaf Harofeh MC

Ẕerifin, Isarel, 40700, Israel

Location

Biospecimen

Retention: NONE RETAINED

urine culture

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Yoram I Siegel, MD

  Assaf Harofeh MC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoram I Siegel, MD

CONTACT

972-8-9779400; yoram.siegel@gmail.com

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 17, 2008
• First Posted: June 20, 2008
• Study Start: August 1, 2008
• Last Updated: June 20, 2008

Record last verified: 2008-05

Locations

IL (1)