Assessing Safety and Performance of the Novel CytaCoat Foley Catheter

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.

NCT Number	NCT07070921
Lead Sponsor	CytaCoat AB Collaborators: Sterimed Surgicals (India) Pvt Ltd
Conditions	Safety of the CytaCoat Foley Catheter, Performance of the CytaCoat Foley Catheter
Enrollment	30 participants
Start Date	2025-06-02
Primary Completion	2025-08 (estimated)
Study Completion	2025-09 (estimated)
Updated on ClinicalTrials.gov	2025-07-17