Status:
COMPLETED
Randomized Study of Silq Urinary Catheter
Lead Sponsor:
Silq Technologies Corporation
Conditions:
Biofilm Formation
UTI
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce biofilm formation in subjects that require a long-term indwelling Foley catheter when compared to other comme...
Detailed Description
A prospective, randomized, multi-center, post-market study in subjects that require a long-term indwelling Foley catheter. A randomly assigned catheter will be inserted using standard techniques. Non...
Eligibility Criteria
Inclusion
- Male or female age ≥ 18 years old;
- Requiring indwelling 16Fr Foley catheter for at least 7 days;
- Able and willing to comply with study procedure; and,
- Able and willing to give informed consent.
Exclusion
- Allergy or sensitivity to any catheter materials used in this study;
- Known urethral stricture which, in the opinion of the investigator, could influence the subject's evaluation of the catheter;
- Planned Prophylactic use of antibiotics for CAUTI or any other infection beyond day 1 of the study (catheter implantation);
- Symptomatic UTI being treated with antibiotics (as determined by the study PI, including at least one of the following: fever, chills, headache, burning sensation, burning of urethra or genital area, blood in urine, foul smelling urine and ≥ 10,000 cfu/mL);
- Any other infection being treated with antibiotics at the time of catheter implantation;
- Subjects requiring bladder irrigation during the study (an active voiding trial in surgical subjects prior to catheter removal is allowed);
- Currently enrolled in another interventional clinical trial;
- Any other condition that, in the opinion of the investigator, precludes study participation or poses a significant hazard in case of study participation; and
- Females who are pregnant or breastfeeding or who plan to become pregnant during the study.
Key Trial Info
Start Date :
December 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2024
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT04841226
Start Date
December 28 2021
End Date
August 15 2024
Last Update
November 29 2024
Active Locations (8)
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1
Urology Associates of Southern Arizona
Tucson, Arizona, United States, 85715
2
Rancho Los Amigos National Rehabilitation Center
Downey, California, United States, 90242
3
West Los Angeles VA Medical Center
Los Angeles, California, United States, 90073
4
Tri Valley Urology Medical Group
Murrieta, California, United States, 92562