The Effect of Surface Acoustic Waves on the Prevention of Colonization in Longterm Indwelling Urinary Caatheters
NCT ID: NCT03090373
Last Updated: 2017-03-24
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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UNKNOWN
NA
63 participants
INTERVENTIONAL
2017-01-01
2018-03-01
Brief Summary
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Detailed Description
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Subjects will be randomized to a control group and the treatment group. The control group will receive standard of care for the care of indwelling urinary catheters, while being attached to a sham UroShield device. The treatment group will receive the same standard of care treatment but will be attached to an active UroShield SAW device.
At baseline and again at 30 days, both the catheter and retained urine from the bladder will be evaluated for the number of live colonies. These numbers will be evaluated to see if there is a difference between the active and sham devices.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Control Group
At catheter replacement subjects will have a sham UroShield device attached to the external portion of the catheter and have it activated for 30 days.
Standard of care for the upkeep and cleanliness of the catheter will be adhered to.
At both the baseline and at the conclusion of 30 days, the distal end of the catheter will be collected as well as a sample of retained urine from the bladder and these samples will be evaluated for bacterial colonization.
UroShield
The UroShield is an externally applied acoustic actuator which generates surface acoustic waves and transmits them along the length of the catheter. The device does not come in direct contact with the subjects.
Treatment Group
At catheter replacement subjects will have an active UroShield device attached to the external portion of the catheter and have it activated for 30 days.
Standard of care for the upkeep and cleanliness of the catheter will be adhered to.
At both the baseline and at the conclusion of 30 days, the distal end of the catheter will be collected as well as a sample of retained urine from the bladder and these samples will be evaluated for bacterial colonization.
UroShield
The UroShield is an externally applied acoustic actuator which generates surface acoustic waves and transmits them along the length of the catheter. The device does not come in direct contact with the subjects.
Interventions
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UroShield
The UroShield is an externally applied acoustic actuator which generates surface acoustic waves and transmits them along the length of the catheter. The device does not come in direct contact with the subjects.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to sign informed consent or have someone authorized to sign informed consent.
Exclusion Criteria
* Previous treatment with Surface Acoustic Waves.
18 Years
ALL
Yes
Sponsors
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Nanovibronix
INDUSTRY
Rosenblum, Jonathan I., DPM
INDIV
Responsible Party
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Locations
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NanoVibronix
Elmsford, New York, United States
Countries
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Other Identifiers
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US-2
Identifier Type: -
Identifier Source: org_study_id
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