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The Effect of Surface Acoustic Waves on the Prevention of Colonization in Longterm Indwelling Urinary Caatheters

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ClinicalTrials.gov Identifier: NCT03090373
Recruitment Status : Unknown
Verified March 2017 by Rosenblum, Jonathan I., DPM.
Recruitment status was:  Enrolling by invitation
First Posted : March 24, 2017
Last Update Posted : March 24, 2017
Sponsor:
Collaborator:
Nanovibronix
Information provided by (Responsible Party):
Rosenblum, Jonathan I., DPM

Brief Summary:
This is a double blinded rct to evaluate the effect of the UroShield SAW transducer on preventing bacterial colonization in longterm indwelling catheters. The duration of the trial is 30 days. The investigator will be quantifying the number of bacterial colonies in the urinary catheter and in the bladder in both the treatment and control group.

Condition or disease Intervention/treatment Phase
Baacterial Colonization Urinary Tract Infections Device: UroShield Not Applicable

Detailed Description:

This is a double blinded Randomized controoled trial of 30 days duration. The trial device is the Uroshield, SAW device which is an externally applied device attached to the external portion of the urinary catheter.

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a double blinded, randomized controlled trial. All involved will be blinded as to whether the supplied UroShield device is active or a sham.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: The UroShield device actuator will activate and create the hum, which is the only sign of its working even in the active device. While the active device will transmit Surface Acoustic Waves, the sham device will work but will not transmit any acoustic waves.
Primary Purpose: Prevention
Official Title: The Effect of Surface Acoustic Waves on the Prevention of Bacterial Colonization in Longterm Indwelling Urinary Catheters
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : March 1, 2018

Arm Intervention/treatment
Sham Comparator: 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.

Device: 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 Name: Surface Acoustic Wave Actuator

Active Comparator: 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.

Device: 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 Name: Surface Acoustic Wave Actuator




Primary Outcome Measures :
  1. Bacterial Colonization [ Time Frame: 30 days ]
    Number of cultured colonies from both the Urinary Catheter and retained urine



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Currently being treated with an indwelling urinary catheter for at least 30 days.
  • Ability to sign informed consent or have someone authorized to sign informed consent.

Exclusion Criteria:

  • Currently being treated for an active Urinary Tract infection.
  • Previous treatment with Surface Acoustic Waves.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090373


Locations
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United States, New York
NanoVibronix
Elmsford, New York, United States, 07055
Sponsors and Collaborators
Rosenblum, Jonathan I., DPM
Nanovibronix

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Responsible Party: Rosenblum, Jonathan I., DPM
ClinicalTrials.gov Identifier: NCT03090373     History of Changes
Other Study ID Numbers: US-2
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will NOT be shared beyond the investigators of this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rosenblum, Jonathan I., DPM:
Catheter
UTI's
Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urologic Diseases