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

Urinary Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03090373
• Other study ID #: US-2
• Status: Enrolling by invitation
• Phase: N/A
• First received: March 20, 2017
• Last updated: March 23, 2017
• Start date: January 1, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2017
• Source: Rosenblum, Jonathan I., DPM
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 63
• Est. completion date: March 1, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Baacterial Colonization
• Urinary Tract Infections

Intervention

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.

Locations

Country	Name	City	State
United States	NanoVibronix	Elmsford	New York

Sponsors (2)

Lead Sponsor	Collaborator
Rosenblum, Jonathan I., DPM	Nanovibronix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial Colonization	Number of cultured colonies from both the Urinary Catheter and retained urine	30 days