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Assessing Safety and Performance of the Novel CytaCoat Foley Catheter
Sponsor: CytaCoat AB
Summary
This study is a prospective, single-center, single-blind, randomized, parallel assignment, controlled study to evaluate the safety and performance of the novel CytaCoat Foley catheter when compared to a Sterimed uncoated Foley catheter. Participants will include male and female adult subjects who require an indwelling urinary catheter for an expected duration of minimum 72 hours to 14 days. The primary purpose of the clinical investigation is to determine whether the novel CytaCoat Foley catheter is safe to use in subjects. Safety is assessed by evaluation of adverse events (according to ISO 14155:2020). The secondary objective is to assess the overall performance of the CytaCoat Foley catheter by evaluating usability experience by the healthcare personnel and subjects measured by using NRS (Numeric Rating Scale) scale. Furthermore, the exploratory objective of this study is to assess for the presence of bacteriuria in urine and fouling / biofilm analysis of the used catheters.
Official title: Assessing the Safety and Performance of the Novel CytaCoat Foley Catheter: A Prospective Randomized Controlled Study
Key Details
Gender
All
Age Range
18 Years - 84 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-06-02
Completion Date
2025-09
Last Updated
2025-07-17
Healthy Volunteers
Yes
Interventions
Foley catheter
Drainage of urine from the bladder by transurethral catheterization with an indwelling Foley catheter of patients in need of a Foley catheter for 3 to 14 days.
Locations (1)
St. John's Medical College Hospital
Bangalore, Karnataka, India