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Device

Silicone-coated Latex 2-Way Foley catheter for Biofilm Formation

N/A
Waitlist Available
Research Sponsored by Hydrophilix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Requiring indwelling 16Fr Foley catheter for at least 7 days
Male or female age ≥ 18 years old;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 to 7 days
Awards & highlights

Study Summary

This trial will compare the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter to other commercially available urinary catheters to see which one reduces biofilm formation better in subjects that require a long-term indwelling Foley catheter.

Who is the study for?
Adults aged 18 or older who need a long-term Foley catheter (16Fr size) for at least 7 days can join. They must be able to follow the study's procedures and give informed consent. People with allergies to catheter materials, urethral strictures, current UTI or other infections treated with antibiotics, needing bladder irrigation during the study, pregnant or breastfeeding women, and those in another trial cannot participate.Check my eligibility
What is being tested?
The trial is testing if the Silq ClearTract™ Silicone Foley Catheter is better at preventing biofilm formation compared to standard urinary catheters in patients requiring long-term use. Participants will be randomly assigned to receive either the Silq catheter or a commercial one.See study design
What are the potential side effects?
Potential side effects may include discomfort during insertion or wear of the catheter, allergic reactions if sensitive to silicone or other materials used in the device, urinary tract infection symptoms like burning sensation and foul-smelling urine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I need a specific catheter in place for at least a week.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 to 7 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 to 7 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biofilm formation

Trial Design

3Treatment groups
Active Control
Group I: Silicone-coated Latex 2-Way Foley catheterActive Control1 Intervention
Up to 82 subjects
Group II: Silq ClearTract™ 100% Silicone 2-Way Foley CatheterActive Control1 Intervention
Up to 82 subjects
Group III: Silver-coated Latex 2-Way Foley CatheterActive Control1 Intervention
Up to 82 subjects

Find a Location

Who is running the clinical trial?

HydrophilixLead Sponsor
Silq Technologies CorporationLead Sponsor
1 Previous Clinical Trials
200 Total Patients Enrolled

Media Library

Silq ClearTract™ 100% Silicone 2-Way Foley Catheter (Device) Clinical Trial Eligibility Overview. Trial Name: NCT04841226 — N/A
Biofilm Formation Research Study Groups: Silicone-coated Latex 2-Way Foley catheter, Silq ClearTract™ 100% Silicone 2-Way Foley Catheter, Silver-coated Latex 2-Way Foley Catheter
Biofilm Formation Clinical Trial 2023: Silq ClearTract™ 100% Silicone 2-Way Foley Catheter Highlights & Side Effects. Trial Name: NCT04841226 — N/A
Silq ClearTract™ 100% Silicone 2-Way Foley Catheter (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04841226 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current head count of individuals involved in this experiment?

"Affirmative. Clinicaltrials.gov data suggests that this medical trial, first posted on December 28th 2021 and updated most recently November 19th 2022, is currently admitting patients. A total of 246 participants are required from 6 different sites."

Answered by AI

Are there any vacancies still available for participants of this trial?

"Per the data available on clinicaltrials.gov, this research study is actively recruiting patients. This project was first publicised on December 28th 2021 and its information has been most recently revised as of November 19th 2022."

Answered by AI

How many research facilities are partaking in this experiment?

"Currently, enrolment is being accepted from 6 different sites located in West Des Moines, Downey and Tucson as well as other nearby locations. Patients seeking to participate should select the closest location in order to mitigate any additional travel requirements."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
West Los Angeles VA Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Randomized Study of Silq Urinary Catheter
2021. "Randomized Study of Silq Urinary Catheter". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04841226.
~49 spots leftby Apr 2025
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