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

March 23, 2017 updated by: Rosenblum, Jonathan I., DPM

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Elmsford, New York, United States, 07055
        • NanoVibronix

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

Yes

Genders Eligible for Study

All

Description

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.

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: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Surface Acoustic Wave Actuator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial Colonization
Time Frame: 30 days
Number of cultured colonies from both the Urinary Catheter and retained urine
30 days

Collaborators and Investigators

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

Sponsor

Rosenblum, Jonathan I., DPM

Collaborators

Nanovibronix

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 (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 31, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 24, 2017

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will NOT be shared beyond the investigators of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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