Evaluation of Safety and Performance of the CytaCoat Lubricious Infection Prevention (LIP) Foley Catheter

Phase 1

Recruiting

• Conditions: Tolerability of the CytaCoat LIP Foley Catheter; Safety of the CytaCoat LIP Foley Catheter

• Registration Number: NCT06242600
• Lead Sponsor: CytaCoat AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-1-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Inclusion Criteria:<br><br> - Will be undergoing a TUR-B procedure.<br><br> - Able to give informed consent by signing and dating the written informed consent<br> document acknowledging their desire to participate in the study.<br><br> - Adults, age 18 to 84 years.<br><br> - Require insertion of a size 12, 14, 16, 18 or 20 French Foley catheter after TUR-B<br> surgery.<br><br> - Be able to understand and comply with the information given in the Patient Consent<br> Form.<br><br>Exclusion Criteria:<br><br> - Vulnerable subjects such as children, pregnant or breastfeeding women, or<br> potentially immune-compromised subjects.<br><br> - Unable to provide informed consent.<br><br> - Has a known bacteriuria or a current urinary tract infection.<br><br> - Has a known bloodstream infection or an infection that requires prolonged antibiotic<br> therapy.<br><br> - Has an ongoing antibiotic therapy.<br><br> - Cannot accommodate a size 12, 14, 16, 18 or 20 Fr Foley catheter or requires a<br> Thiemann tip Foley catheter.<br><br> - Previous enrolment in the present study.<br><br> - Simultaneous participation in another clinical study that may impact the primary<br> endpoint.<br><br> - Severe non-compliance to protocol as judged by the PI.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of incidence of adverse events and serious adverse events (safety and tolerability) of the CytaCoat LIP Foley catheter

Secondary Outcome Measures

Name	Time	Method
Assessment of the overall performance of the CytaCoat LIP Foley catheter