Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage

September 28, 2016 updated by: HaEmek Medical Center, Israel

Evaluation of "UroShield" device impact upon side effects and complications of urinary catheter usage.

The use of urinary catheters is a common medical practice in the perioperative setting.

As such, it exposes the patient to certain comorbidities, including urinary tract infections.

The infectious process is known to begin with a development of a biofilm on the catheter's surface. This fact makes it an attractive target for UTI prevention technology.

Ultrasound waves were shown to reduce biofilm buildup in-vitro. We plan to determine the efficacy of this method in vivo.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who need to insert a catheter urine as part of their treatment and rehabilitation at the orthopedic ward.

Exclusion Criteria:

  1. Patients undergoing an invasive procedure in the past month some urinary tract, or the existence of a well-known structural pathology.
  2. patients with a urinary tract infection in the past year.
  3. Patients with a urinary tract infection when inserting a catheter.
  4. pregnant women.
  5. Patients under the age of 18.
  6. without judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients receive active UroShield device
Device: UroShield device
The UroShield device is Consists of two units:Actuator and Driver.
Sham Comparator: Patients receive inactive UroShield device
Device: Sham UroShield device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effects and complications of urinary catheter usage
Time Frame: One Year
the measure is a composite of :complaints related to the uro-genital system, the results of blood and urine tests, monitoring fever, blood pressure and pulse
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

August 1, 2017

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

April 1, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0116-14-EMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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