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Procedure
SILQ ClearTract Catheter for Chronic Urinary Retention
N/A
Recruiting
Led By Evgeniy Kreydin, M.D.
Research Sponsored by Silq Technologies Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial compares the safety of a new Foley catheter to existing ones to reduce medical complications.
Who is the study for?
This trial is for adults over 18 who need a long-term urinary catheter (14Fr, 16Fr, or 18Fr) for bladder drainage and can follow the study's procedures. They must be able to consent to participate. People with past bladder reconstruction surgery, allergies to catheter materials, or cognitive issues affecting questionnaire responses cannot join.Check my eligibility
What is being tested?
The trial is testing the Silq ClearTract™ Silicone Foley Catheter's effectiveness in reducing complications like infections and blockages compared to other Foley catheters in patients requiring long-term use.See study design
What are the potential side effects?
Potential side effects may include discomfort during insertion or removal of the catheter, urinary tract infections, irritation at the insertion site, and possible blockage or calcification of the catheter.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been using a specific size urinary catheter for bladder drainage for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Catheter Related Complications
Secondary outcome measures
Catheter Encrustation
Catheter Related Complication Treatment Costs
Patient Preference
+1 moreTrial Design
2Treatment groups
Active Control
Group I: SILQ ClearTract 100% Silicone 2-Way Foley CatheterActive Control1 Intervention
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.
Group II: Standard of Care CatheterActive Control1 Intervention
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
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Who is running the clinical trial?
Silq Technologies CorporationLead Sponsor
1 Previous Clinical Trials
158 Total Patients Enrolled
Evgeniy Kreydin, M.D.Principal InvestigatorRancho Los Amigos National Rehabilitation Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have difficulty understanding or answering questions due to cognitive issues.I have had surgery to reconstruct my bladder.I have been using a specific size urinary catheter for bladder drainage for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: SILQ ClearTract 100% Silicone 2-Way Foley Catheter
- Group 2: Standard of Care Catheter
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollment slots still open for this research endeavor?
"Data hosted on clinicaltrials.gov shows that recruitment for this trial is no longer taking place, as the last update was posted on June 30th 2023. However, there are 42 other trials seeking participants at present."
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