Randomized Study of Silq Urinary Catheter
Completed · Not applicable
Conditions studied: Biofilm Formation, UTI
In brief
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 commercially available urinary catheters.
Key facts
- Study ID
- NCT04841226
- Run by
- Silq Technologies Corporation
- People needed
- 158
- Starts
- 2021-12-28
- Expected to finish
- 2024-08-15
- Last updated by the study team
- 2024-11-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Urology Associates of Southern Arizona — Tucson, Arizona, United States
- Rancho Los Amigos National Rehabilitation Center — Downey, California, United States
- West Los Angeles VA Medical Center — Los Angeles, California, United States
- Tri Valley Urology Medical Group — Murrieta, California, United States
- Providence Saint John's Health Center — Santa Monica, California, United States
- The Iowa Clinic — West Des Moines, Iowa, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Evergreen Health — Kirkland, Washington, United States
Full record on ClinicalTrials.gov
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