Assessing Safety and Performance of the Novel CytaCoat Foley Catheter
Recruiting
N/A
Interventional Study
Safety of the CytaCoat Foley Catheter
Performance of the CytaCoat Foley Catheter
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 84
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 30 (estimated)
- Sponsor
- CytaCoat AB · Industry
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About This Trial
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 p…
Trial Locations
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Eligibility 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…
Contacts
Mathangi Krishnakumar, MD
+91 9764062212
CONTACT