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Assessing Safety and Performance of the Novel CytaCoat Foley Catheter

RecruitingNAAges 18 Years - 84 YearsAllCytaCoat AB
NCT07070921 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Foley catheter
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Where

1 site
St. John's Medical College Hospital
Bangalore, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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