Actively Recruiting
Assessing Safety and Performance of the Novel CytaCoat Foley Catheter
Led by CytaCoat AB · Updated on 2025-07-17
30
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
C
CytaCoat AB
Lead Sponsor
S
Sterimed Surgicals (India) Pvt Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessing Safety and Performance of the Novel CytaCoat Foley Catheter
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults, male and female, aged 18 to 84 years
- Need for a urinary catheter for at least 72 hours
- Ability to accommodate a size of 14, 16, or 18 French Foley catheter
- Written informed consent provided
- Subject must be conscious
You will not qualify if you...
- Pregnant or breastfeeding women
- Critically ill subjects with life-threatening disorders (APACHE II score 28 or higher)
- Known allergy or sensitivity to silicone
- Previous participation in this study
- Concurrent participation in another clinical study that affects the primary outcome
- Existing urinary catheter in place for more than 48 hours
- Symptomatic genitourinary conditions
- Expected inability to comply with the study protocol as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. John's Medical College Hospital
Bangalore, Karnataka, India, 560034
Actively Recruiting
Research Team
S
Soumya Madhusudhan, MD
CONTACT
M
Mathangi Krishnakumar, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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