Biofilm FormationNCT04841226
Randomized Study of Silq Urinary Catheter
A study testing Long-term indwelling Foley catheter in people with Biofilm Formation and UTI, run by Silq Technologies Corporation at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biofilm Formation, UTI
- What is being tested?
- Long-term indwelling Foley catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 8 sitesUnited States
- Study dates
- 28 Dec 2021to 15 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 9Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
Evergreen Health
Kirkland, Washington, 98034
West Los Angeles VA Medical Center
Los Angeles, California, 90073
Tri Valley Urology Medical Group
Murrieta, California, 92562
Providence Saint John's Health Center
Santa Monica, California, 90404
Montefiore Medical Center
The Bronx, New York, 10461
Urology Associates of Southern Arizona
Tucson, Arizona, 85715
The Iowa Clinic
West Des Moines, Iowa, 50266
About this study
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)
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.
Read the 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.
- Conditions
- Biofilm Formation, UTI
- Being tested
- Long-term indwelling Foley catheter
- Keywords
- Urinary Catheter, Foley
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term indwelling Foley catheterDevice
Foley Catheter inserted for up to 28-days
| Study group | Role | What they receive |
|---|---|---|
| Silq ClearTract™ 100% Silicone 2-Way Foley Catheter | Active comparator | Up to 82 subjects Receives: Device: Long-term indwelling Foley catheter |
| Silver-coated Latex 2-Way Foley Catheter | Active comparator | Up to 82 subjects Receives: Device: Long-term indwelling Foley catheter |
| Silicone-coated Latex 2-Way Foley catheter | Active comparator | Up to 82 subjects Receives: Device: Long-term indwelling Foley catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biofilm formation
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.
Measured: 5 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start28 Dec 2021
- Primary completion31 Mar 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biofilm FormationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silq Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841226
- Sponsor's protocol ID
- STC-001/F
- Status last verified
- Nov 2024
- First submitted
- 7 Apr 2021
- Last updated
- 29 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04841226
- Acronym / sponsor ID
- STC-001/F
- Conditions
- Biofilm Formation, UTI
- Keywords
- Urinary Catheter, Foley
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Silq Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Silq ClearTract™ 100% Silicone 2-Way Foley Catheter | Active comparator | Device: Long-term indwelling Foley catheterUp to 82 subjects |
| Silver-coated Latex 2-Way Foley Catheter | Active comparator | Device: Long-term indwelling Foley catheterUp to 82 subjects |
| Silicone-coated Latex 2-Way Foley catheter | Active comparator | Device: Long-term indwelling Foley catheterUp to 82 subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-term indwelling Foley catheterFoley Catheter inserted for up to 28-days | Device | Silicone-coated Latex 2-Way Foley catheter, Silq ClearTract™ 100% Silicone 2-Way Foley Catheter, Silver-coated Latex 2-Way Foley Catheter |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
Related trials for Biofilm Formation
Not yet recruitingObservational study
Gene Expression Analysis of Biofilm Formation and Antimicrobial Resistance in Clinical Methicillin-Resistant Staphylococcus Aureus
Staphylococcal Aureus Infection, Surgical Site Infection (SSI)
Recruiting
Investigation of Biofilm Formation on Temporary push-on Rings of Implant Crowns
Dental Plaque, Oral Biofilm
Not yet recruiting
Development of Biofunctional 3D-Printed Orthodontic Aligners With Antimicrobial and Remineralizing Properties
Orthodontic Aligner Material, Enamel Demineralization
Not yet recruitingObservational study
Phenotypic and Genotypic Detection of Biofilm Formation and Efflux Pump Activity in Multi-drug Resistant Klebsiella Pneumoniae
Multidrug Resistant Klebsiella Pneumoniae Infection
Not yet recruitingObservational study
Antibiofilm Activity of Chitosan Nanoparticles Against Uropathogenic Escherichia Coli
Urinary Tract Infections (UTIs), Catheter-Associated Urinary Tract Infections (CAUTIs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-term indwelling Foley catheter in people with Biofilm Formation and UTI, run by Silq Technologies Corporation at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biofilm formation (time frame: 5 to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.