NCT04841226

Randomized Study of Silq Urinary Catheter

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Silq Technologies Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DEVICE	Long-term indwelling Foley catheter	Foley Catheter inserted for up to 28-days

Timeline

• Start date: 2021-12-28
• Primary completion: 2024-03-31
• Completion: 2024-08-15
• First posted: 2021-04-12
• Last updated: 2024-11-29

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study