CompletedNot Applicable

Randomized Study of Silq Urinary Catheter

United States158 participantsStarted 2021-12-28

Plain-language 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 commercially available urinary catheters.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Biofilm formation

Timeframe: 5 to 7 days

Trial details

NCT IDNCT04841226

SponsorSilq Technologies Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-31

View on ClinicalTrials.gov More Biofilm Formation trials