The Use of the UroShield Device in Patients With Indwelli... | NCT00446732

Studies
The Use of the UroShield Device in Patients With Indwelling Urinary Catheters

NCT00446732

Sponsor

Nanovibronix

Status

Unknown status

Last Update Posted

Mar 25, 2009Estimated

Enrollment

200Estimated

Phase

Phase 2Phase 3

Conditions

Urinary Tract Infection

Interventions

UroSshield

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Apr 2009Estimated

Completion Date

Jun 2009Estimated

First Submitted Date

Mar 11, 2007

First Submission Date that Met QC Criteria

Mar 12, 2007

First Posted Date

Mar 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2009

Last Update Posted Date

Mar 25, 2009Estimated

Name	Class
Shaare Zedek Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

According to the Israeli Ministry of Health requirement, this study was designed to evaluate the efficacy of the UroShield system is patients that require urinary catheterization. This was designed to compare standard treatment (urinary catheter alone) with the UroShield treatment in occurrence of catheter associated Urinary Tract infection, pain, discomfort, Biofilm prevention and trauma.

Detailed Description

This study is aimed at assessing the effectiveness of the NanoVibronix™ UroShield™ System in comparison to Urinary catheter alone in patients requiring urinary catheterization.

Primary objectives
- To observe the effect of UroShield in reduction of patient's complaints relating to indwelling Urinary Catheters
  - Pain
  - Discomfort
- To observe the effect of UroShield in the reduction/prevention of Biofilm
- To observe the effect of UroShield on the occurrence of bacteriuria and/or UTI's on patients with Indwelling Urinary Catheters
Safety Objective To assess the safety parameters of the UroShield system
Secondary Objectives
- To observe the effect of UroShield in reduction of Foley Catheter related pain medication in patients with Indwelling Urinary Catheters
- To observe the effect of UroShield in reduction of antibiotic medication in patients with Indwelling Urinary Catheter
- To observe the effect of UroShield on the clogging of Urinary Catheter when used chronically and the need to replace the catheter
- To observe the effect of UroShield on the decrease of Tissue damage of patients with Indwelling Urinary Catheters by measuring cell count before and after removal of catheter

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Device: UroSshield
2	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UroSshield	Device	Attachment of the UroShield device to the external part of the urinary catheter	1

Measure	Description	Time Frame
primary end points		up to 14 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalized patients age 18 years or older
Patients requiring or having catheterization for more than 24 hours
Patient able, agrees and signs the Informed Consent Form

Exclusion Criteria:

Pregnant or breastfeeding women. Women of child bearing potential will perform a pregnancy test before inclusion into the study
Presence of any clinically relevant known urinary tract infection
Patient with condition who is not expected to survive the study period
Known HIV positive
Patient has any condition, which precludes compliance with study and/or device instructions.
Patient is currently participating in another clinical study.
Known allergy to latex

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ofer Shenfeld, MD	Contact	972-2-6555560		shenfeld@szmc.org.il

Overall Officials

Name	Affiliation	Role
Ofer Shenfeled, MD	Sharei Zedek	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaare Zedek Medical Center	Recruiting	Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided