Catheter InfectionNCT05931887
Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention
A study testing SILQ ClearTract 100% Silicone 2-Way Foley Catheter in people with Catheter Infection and Catheter Blockage, run by Silq Technologies Corporation at 1 site in United States.
Trial summary
To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce catheter associated complications in subjects that require a long-term indwelling Foley catheter when compared to other commercially available Foley catheters. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Catheter Infection, Catheter Blockage, Catheter Related Complication
- What is being tested?
- SILQ ClearTract 100% Silicone 2-Way Foley Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2023to 18 Apr 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Requirement of a 14 Fr, 16Fr, or 18Fr indwelling urethral or suprapubic urinary catheter (for at least 6 months) for bladder drainage.
- Able and willing to comply with study procedures
- Able and willing to give informed consent.
Who cannot join
- History of reconstructive bladder surgery such as bladder augmentation or continent catheterizable stoma.
- Cognitive deficit limiting the ability to respond to clinical questionnaires.
- Allergy or sensitivity to any catheter material used in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rancho Los Amigos National Rehabilitation Center
Downey, California, 90242
About this study
To assess the ability of the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to reduce catheter associated complications in subjects that require a long-term indwelling Foley catheter when compared to other commercially available Foley catheters.
Read the detailed description
A prospective, randomized, multi-center, post-market study in subjects that require a long-term indwelling Foley catheter.
Neurogenic bladder is commonly managed with indwelling catheters (urethral or suprapubic). Indwelling catheters are associated with multiple complications, including recurrent urinary tract infections and catheter obstruction. A randomly assigned catheter will be inserted using standard techniques. The assigned catheters will either be the SILQ ClearTract 100% Silicone 2-Way Foley Catheter or the current standard of care catheter. Subjects will continue to use the assigned catheter for a period of approximately 3 months following regular standard of care. Subjects will then be assigned the alternative catheter for an additional 3 month period after which they will be exited from the study
The purpose of the study is to compare the incidence of catheter-related complications between the SILQ treated catheter and the current standard of care catheter(s). Because these complications lead to more frequent interventions and associated treatment costs, the study will also calculate the economic impact of the use of SILQ treated catheters compared to standard of care catheters. Patient-reported outcomes will also be measured via questionnaires upon each study visit. Explanted catheter samples will also be sent to a core lab for quantification of the calcification present on the catheter surface.
- Conditions
- Catheter Infection, Catheter Blockage, Catheter Related Complication, Catheter Calcification
- Being tested
- SILQ ClearTract 100% Silicone 2-Way Foley Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SILQ ClearTract 100% Silicone 2-Way Foley CatheterDevice
A foley catheter is assigned and used according to regular standard of care
| Study group | Role | What they receive |
|---|---|---|
| SILQ ClearTract 100% Silicone 2-Way Foley Catheter | Active comparator | Subjects in this arm will receive the SILQ ClearTract 100% Silicone 2-Way Foley Catheter for approximately the first 3 month period of enrollment. In a subsequent period of approximately 3 months subjects in this arm will receive their current standard of care catheter. Receives: Device: SILQ ClearTract 100% Silicone 2-Way Foley Catheter |
| Standard of Care Catheter | Active comparator | Subjects in this arm will receive their current Standard of Care Catheter for the first 3 month period of enrollment. In a subsequent period of approximately 3 months subjects in this arm will receive the SILQ ClearTract 100% Silicone 2-Way Foley Catheter Receives: Device: SILQ ClearTract 100% Silicone 2-Way Foley Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Catheter Related Complications
Catheter Related Complications can be classified as:
- Symptomatic Catheter Associated Urinary Tract Infection ii. Catheter Blockage iii. General Premature Interventions: Patient sought care for a catheter-related issue prior to their scheduled catheter exchange
Measured: 6 months
Secondary outcomes (4)
Catheter Related Complication Treatment Costs
All data related to complications and associated treatments will be tabulated. Corresponding treatment costs for each complication will be tabulated.
Measured: 6 months
Catheter Encrustation
Quantitative chemical and gravimetric analysis of encrustation of removed catheters
Measured: 6 months
Patient Preference
During the first exchange after the crossover, subjects will be asked which catheter they would prefer to continue to use
Measured: 4 months
Patient Satisfaction
Pain and discomfort will be assessed upon each foley catheter removal using a 5 point scale. A score of 1 indicates no pain or discomfort and a score of 5 indicates severe pain or discomfort.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start26 Jul 2023
- Primary completion31 Dec 2025
- Study completion18 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter InfectionStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silq Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Evgeniy Kreydin, M.D., Principal investigator, Rancho Los Amigos National Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931887
- Sponsor's protocol ID
- STC002
- Status last verified
- Apr 2026
- First submitted
- 16 Jun 2023
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Novel Silq ClearTract Catheter in Patients With Chronic Urinary Retention
- ClinicalTrials.gov ID
- NCT05931887
- Acronym / sponsor ID
- STC002
- Conditions
- Catheter Infection, Catheter Blockage, Catheter Related Complication, Catheter Calcification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Silq Technologies CorporationIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 18 Apr 2026 (actual)
- First posted
- 5 Jul 2023 (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 catheter associated complications in subjects that require a long-term indwelling Foley catheter when compared to other commercially available Foley catheters.
Detailed description
A prospective, randomized, multi-center, post-market study in subjects that require a long-term indwelling Foley catheter.
Neurogenic bladder is commonly managed with indwelling catheters (urethral or suprapubic). Indwelling catheters are associated with multiple complications, including recurrent urinary tract infections and catheter obstruction. A randomly assigned catheter will be inserted using standard techniques. The assigned catheters will either be the SILQ ClearTract 100% Silicone 2-Way Foley Catheter or the current standard of care catheter. Subjects will continue to use the assigned catheter for a period of approximately 3 months following regular standard of care. Subjects will then be assigned the alternative catheter for an additional 3 month period after which they will be exited from the study
The purpose of the study is to compare the incidence of catheter-related complications between the SILQ treated catheter and the current standard of care catheter(s). Because these complications lead to more frequent interventions and associated treatment costs, the study will also calculate the economic impact of the use of SILQ treated catheters compared to standard of care catheters. Patient-reported outcomes will also be measured via questionnaires upon each study visit. Explanted catheter samples will also be sent to a core lab for quantification of the calcification present on the catheter surface.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SILQ ClearTract 100% Silicone 2-Way Foley Catheter | Active comparator | Device: SILQ ClearTract 100% Silicone 2-Way Foley CatheterSubjects in this arm will receive the SILQ ClearTract 100% Silicone 2-Way Foley Catheter for approximately the first 3 month period of enrollment. In a subsequent period of approximately 3 months subjects in this arm will receive their current standard of care catheter. |
| Standard of Care Catheter | Active comparator | Device: SILQ ClearTract 100% Silicone 2-Way Foley CatheterSubjects in this arm will receive their current Standard of Care Catheter for the first 3 month period of enrollment. In a subsequent period of approximately 3 months subjects in this arm will receive the SILQ ClearTract 100% Silicone 2-Way Foley Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years old
- Requirement of a 14 Fr, 16Fr, or 18Fr indwelling urethral or suprapubic urinary catheter (for at least 6 months) for bladder drainage.
- Able and willing to comply with study procedures
- Able and willing to give informed consent.
Key exclusion criteria (3 listed)
- History of reconstructive bladder surgery such as bladder augmentation or continent catheterizable stoma.
- Cognitive deficit limiting the ability to respond to clinical questionnaires.
- Allergy or sensitivity to any catheter material used in this study.
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 |
|---|---|---|
| SILQ ClearTract 100% Silicone 2-Way Foley CatheterA foley catheter is assigned and used according to regular standard of care | Device | SILQ ClearTract 100% Silicone 2-Way Foley Catheter, Standard of Care Catheter |
Primary outcome
Number of Catheter Related Complications
Time frame: 6 months
Catheter Related Complications can be classified as: i. Symptomatic Catheter Associated Urinary Tract Infection ii. Catheter Blockage iii. General Premature Interventions: Patient sought care for a catheter-related issue prior to their scheduled catheter exchange
4 secondary outcomes
Catheter Related Complication Treatment Costs
Time frame: 6 months
Catheter Encrustation
Time frame: 6 months
Patient Preference
Time frame: 4 months
Patient Satisfaction
Time frame: 6 months
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 24 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Evgeniy Kreydin, M.D. principal investigator
Rancho Los Amigos National Rehabilitation Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SILQ ClearTract 100% Silicone 2-Way Foley Catheter in people with Catheter Infection and Catheter Blockage, run by Silq Technologies Corporation at 1 site 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 3 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 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of Catheter Related Complications (time frame: 6 months). 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 24 Apr 2026.