Assessing Safety and Performance of the Novel CytaCoat Foley Catheter

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Assessment of Safety through incidence of adverse events and serious adverse events of the CytaCoat Foley catheter. — 3 - 14 days
  Adverse events (AEs) and serious adverse events (SAEs) which are further divided into adverse device effects (ADEs) and serious ADEs (SADEs) will be assessed.

Trial sites (1)