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Surface Acoustic Waves
Treatment Group for Urinary Tract Infection
N/A
Waitlist Available
Research Sponsored by Rosenblum, Jonathan I., DPM
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
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.
Eligible Conditions
- Urinary Tract Infection
- Bacterial Colonization
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bacterial Colonization
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Treatment GroupActive Control1 Intervention
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.
Group II: Control GroupPlacebo Group1 Intervention
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.
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Who is running the clinical trial?
Rosenblum, Jonathan I., DPMLead Sponsor
3 Previous Clinical Trials
105 Total Patients Enrolled
NanovibronixIndustry Sponsor
6 Previous Clinical Trials
404 Total Patients Enrolled
2 Trials studying Urinary Tract Infection
224 Patients Enrolled for Urinary Tract Infection
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