NCT00446732

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

2.1 years

First QC Date

March 11, 2007

Last Update Submit

March 24, 2009

Conditions

Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

  • primary end points

    up to 14 days

Study Arms (2)

1

ACTIVE COMPARATOR
Device: UroSshield

2

NO INTERVENTION

Interventions

UroSshieldDEVICE

Attachment of the UroShield device to the external part of the urinary catheter

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Ofer Shenfeled, MD

    Sharei Zedek

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ofer Shenfeld, MD

CONTACT

972-2-6555560shenfeld@szmc.org.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 11, 2007

First Posted

March 13, 2007

Study Start

March 1, 2007

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

IL(1)