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Randomized Study of Silq Urinary Catheter

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ClinicalTrials.gov Identifier: NCT04841226
Recruitment Status : Recruiting
First Posted : April 12, 2021
Last Update Posted : February 17, 2023
Sponsor:
Information provided by (Responsible Party):
Silq Technologies Corporation

Study Description
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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 commercially available urinary catheters.

Condition or disease Intervention/treatment Phase
Biofilm Formation UTI Device: Long-term indwelling Foley catheter Not Applicable

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-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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Prospective, Multi-Center, Randomized Study to Assess the Ability of the Silq ClearTract™ Urinary Catheter to Reduce Biofilm Formation When Compared to Two Types of Commercially Available Foley Catheters (Silver-Coated Latex and Silicone-coated Latex)
Actual Study Start Date : December 28, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Silq ClearTract™ 100% Silicone 2-Way Foley Catheter
Up to 82 subjects
 Device: Long-term indwelling Foley catheter
Foley Catheter inserted for up to 28-days
Active Comparator: Silver-coated Latex 2-Way Foley Catheter
Up to 82 subjects
 Device: Long-term indwelling Foley catheter
Foley Catheter inserted for up to 28-days
Active Comparator: Silicone-coated Latex 2-Way Foley catheter
Up to 82 subjects
 Device: Long-term indwelling Foley catheter
Foley Catheter inserted for up to 28-days


Outcome Measures
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Primary Outcome Measures :
  1. Biofilm formation [ Time Frame: 5 to 7 days ]
    A core lab will use the BacTiter-Glo Microbial Cell Viability Assay, a well characterized method for quantifying active biomass and biofilm, to determine biofilm formation on explanted catheter samples.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04841226


Contacts
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Contact: Brian McVerry, PhD 949-735-2614 brianm@silq.tech

Locations
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United States, Arizona
Urology Associates of Southern Arizona Recruiting
Tucson, Arizona, United States, 85715
Contact: Jasmine Simpson    520-661-8126      
United States, California
Rancho Los Amigos National Rehabilitation Center Active, not recruiting
Downey, California, United States, 90242
West Los Angeles VA Medical Center Recruiting
Los Angeles, California, United States, 90073
Contact: Scott Zeitlin, MD    301-478-3711 ext 43847      
Tri Valley Urology Medical Group Recruiting
Murrieta, California, United States, 92562
Contact: Natalie Nealeigh, PA-C    951-698-1901 ext 232    research@trivalleyurology.com   
Providence Saint John's Health Center Completed
Santa Monica, California, United States, 90404
United States, Iowa
The Iowa Clinic Recruiting
West Des Moines, Iowa, United States, 50266
Contact: Emily Audlehelm, RN    515-875-9239      
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Andrea Asencio    347-842-1715      
United States, Washington
Evergreen Health Recruiting
Kirkland, Washington, United States, 98034
Contact: Lora Plaskon, MD    425-899-5385      
Sponsors and Collaborators
Silq Technologies Corporation
More Information
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Responsible Party: Silq Technologies Corporation
ClinicalTrials.gov Identifier: NCT04841226    
Other Study ID Numbers: STC-001/F
First Posted: April 12, 2021    Key Record Dates
Last Update Posted: February 17, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Silq Technologies Corporation:
Urinary Catheter
Foley