Randomized Study of Silq Urinary Catheter

Last updated: November 26, 2024
Sponsor: Silq Technologies Corporation
Overall Status: Completed

Phase

N/A

Condition

Urinary Tract Infections

Treatment

Long-term indwelling Foley catheter

Clinical Study ID

NCT04841226
STC-001/F
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female age ≥ 18 years old;

  2. Requiring indwelling 16Fr Foley catheter for at least 7 days;

  3. Able and willing to comply with study procedure; and,

  4. Able and willing to give informed consent.

Exclusion

Exclusion Criteria:

  1. Allergy or sensitivity to any catheter materials used in this study;

  2. Known urethral stricture which, in the opinion of the investigator, could influencethe subject's evaluation of the catheter;

  3. Planned Prophylactic use of antibiotics for CAUTI or any other infection beyond day 1 of the study (catheter implantation);

  4. 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 ≥ 10,000cfu/mL);

  5. Any other infection being treated with antibiotics at the time of catheterimplantation;

  6. Subjects requiring bladder irrigation during the study (an active voiding trial insurgical subjects prior to catheter removal is allowed);

  7. Currently enrolled in another interventional clinical trial;

  8. Any other condition that, in the opinion of the investigator, precludes studyparticipation or poses a significant hazard in case of study participation; and

  9. Females who are pregnant or breastfeeding or who plan to become pregnant during thestudy.

Study Design

Total Participants: 158
Treatment Group(s): 1
Primary Treatment: Long-term indwelling Foley catheter
Phase:
Study Start date:
December 28, 2021
Estimated Completion Date:
August 15, 2024

Study 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-surgical subjects will rate the level of pain associated with the insertion procedure using the visual analog scale (VAS). A urine sample will be collected immediately after catheter insertion, in order to generate a baseline urinalysis and urine culture.

Follow-up visits will be performed on Day 28, or upon catheter removal, whichever occurs first. The catheter will be removed on Day 28 or earlier if clinically indicated. The removed catheter will be processed and sent to the core laboratory for analysis. Urine will be collected immediately prior to catheter removal in order to conduct urinalysis and urine culture. Subject will rate level of pain associated with the removal procedure using the VAS. The subject will also fill out a questionnaire about their experience with the catheterization immediately after catheter removal. Subjects will then be exited from the study.

Connect with a study center

  • Urology Associates of Southern Arizona

    Tucson, Arizona 85715
    United States

    Site Not Available

  • Rancho Los Amigos National Rehabilitation Center

    Downey, California 90242
    United States

    Site Not Available

  • West Los Angeles VA Medical Center

    Los Angeles, California 90073
    United States

    Site Not Available

  • Tri Valley Urology Medical Group

    Murrieta, California 92562
    United States

    Site Not Available

  • Providence Saint John's Health Center

    Santa Monica, California 90404
    United States

    Site Not Available

  • The Iowa Clinic

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • Evergreen Health

    Kirkland, Washington 98034
    United States

    Site Not Available

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