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

NCT ID: NCT02412891

Last Updated: 2016-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infectious

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Patients receive active UroShield device

Patients receive active UroShield device

Group Type ACTIVE_COMPARATOR

UroShield device

Intervention Type DEVICE

The UroShield device is Consists of two units:Actuator and Driver.

Patients receive inactive UroShield device

Patients receive inactive UroShield device

Group Type SHAM_COMPARATOR

Sham UroShield device

Intervention Type DEVICE

Interventions

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UroShield device

The UroShield device is Consists of two units:Actuator and Driver.

Intervention Type DEVICE

Sham UroShield device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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0116-14-EMC

Identifier Type: -

Identifier Source: org_study_id

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