Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
158 participants
INTERVENTIONAL
2021-12-28
2024-08-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Silq ClearTract™ 100% Silicone 2-Way Foley Catheter
Up to 82 subjects
Long-term indwelling Foley catheter
Foley Catheter inserted for up to 28-days
Silver-coated Latex 2-Way Foley Catheter
Up to 82 subjects
Long-term indwelling Foley catheter
Foley Catheter inserted for up to 28-days
Silicone-coated Latex 2-Way Foley catheter
Up to 82 subjects
Long-term indwelling Foley catheter
Foley Catheter inserted for up to 28-days
Interventions
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Long-term indwelling Foley catheter
Foley Catheter inserted for up to 28-days
Eligibility Criteria
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Inclusion Criteria
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 Criteria
2. Known urethral stricture which, in the opinion of the investigator, could influence the 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 ≥ 10,000 cfu/mL);
5. Any other infection being treated with antibiotics at the time of catheter implantation;
6. Subjects requiring bladder irrigation during the study (an active voiding trial in surgical 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 study participation 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 the study.
18 Years
ALL
No
Sponsors
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Silq Technologies Corporation
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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STC-001/F
Identifier Type: -
Identifier Source: org_study_id