CytaCoat Foley catheter safety and performance comparison
Assessing the Safety and Performance of the Novel CytaCoat Foley Catheter: A Prospective Randomized Controlled Study
This study will test whether the CytaCoat Foley catheter is safe and easier to use than a standard silicone Foley catheter in adults who need an indwelling urinary catheter for 3 to 14 days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 84 Years |
| Sex | All |
| Sponsor | CytaCoat AB Industry-sponsored |
| Locations | 1 site (Bangalore, Karnataka) |
| Trial ID | NCT07070921 on ClinicalTrials.gov |
What this trial studies
This is a prospective, single-center, single-blind, randomized, parallel-group comparison of the novel CytaCoat Foley catheter versus a standard Sterimed silicone Foley catheter in adults needing an indwelling urinary catheter for 72 hours to 14 days. The primary outcome is device safety measured by adverse events and serious adverse events documented according to ISO 14155:2020. Secondary outcomes include overall performance and usability scored by healthcare personnel and subjects using a Numeric Rating Scale (NRS). An exploratory analysis will look for bacteriuria and examine fouling/biofilm on removed catheters.
Who should consider this trial
Good fit: Adults aged 18–84 who are conscious, can consent, need an indwelling urinary catheter for at least 72 hours (up to 14 days), and can accommodate a 14, 16, or 18 French catheter.
Not a fit: People who are pregnant or breastfeeding, critically ill with APACHE II ≥ 28, have a known silicone allergy, have had a catheter in place >48 hours, or have symptomatic genitourinary pathology are unlikely to be eligible or to benefit from this study.
Why it matters
Potential benefit: If successful, the CytaCoat catheter could reduce catheter fouling and improve patient comfort and ease of insertion/removal.
How similar studies have performed: Other coated or antimicrobial Foley catheters have shown mixed but sometimes positive effects on biofilm formation and bacteriuria in prior studies, though results vary by coating and setting.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults, male and female, aged 18 to 84 years * Subjects in need of a urinary catheter for a minimum of 72 hours * Subjects who can accommodate a size of 14, 16 and 18 French Foley catheter * Written informed consent * Subject to be conscious Exclusion Criteria: * Pregnant or breastfeeding women * Critically ill subjects with a life-threatening disorder (Subjects having an APACHE II score ≥ 28) * Subject with a known silicone allergy or sensitivity * Previous enrolment in the present study * Simultaneous participation in another clinical study that may impact the primary endpoint * Subject with pre-existing urinary catheter for more than 48 hours * Subject with symptomatic genitourinary pathology * Expected severe non-compliance to the protocol as judged by the principal investigator
Where this trial is running
Bangalore, Karnataka
- St. John's Medical College Hospital — Bangalore, Karnataka, India (Recruiting)
Study contacts
- Principal investigator: Soumya Madhusudhan, MD — Department of Neuro ICU, St John's Medical College Hospital
- Study coordinator: Soumya Madhusudhan, MD
- Email: soumyadnb@gmail.com
- Phone: +91 9980174748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.