Evaluation of "UroShield" Device Impact Upon Side Effects and Complications of Urinary Catheter Usage
NCT ID: NCT02412891
Last Updated: 2016-09-29
Study Results
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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WITHDRAWN
NA
INTERVENTIONAL
2015-08-31
2017-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Patients receive active UroShield device
Patients receive active UroShield device
UroShield device
The UroShield device is Consists of two units:Actuator and Driver.
Patients receive inactive UroShield device
Patients receive inactive UroShield device
Sham UroShield device
Interventions
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UroShield device
The UroShield device is Consists of two units:Actuator and Driver.
Sham UroShield device
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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HaEmek Medical Center, Israel
OTHER
Responsible Party
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Other Identifiers
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0116-14-EMC
Identifier Type: -
Identifier Source: org_study_id
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