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

Early Phase 1

Completed

• Conditions: Safety of the CytaCoat LIP Foley Catheter; Tolerability of the CytaCoat LIP Foley Catheter
• Interventions: Device: Drainage of the bladder by indwelling Foley catheter

• Registration Number: NCT06242600
• Lead Sponsor: CytaCoat AB

Brief Summary

The goal of this pilot safety and tolerability study is to determine whether the novel CytaCoat LIP (Lubricious Infection Prevention) Foley catheter is safe to use in patients during short term use.

The primary objective of this study is to determine the safety and tolerability for the medical device CytaCoat LIP Foley catheter in patients undergoing Transurethral Resection of the Bladder (TUR-B) surgery. Safety will be assessed by evaluation of adverse events.

The secondary objective is to assess the overall performance by evaluating if there were any Foley catheter handling problems experienced by the healthcare personnel with the use of the CytaCoat LIP Foley catheter.

Exploratory objectives are to assess bacterial culture of urine samples taken before and after catheterization and to assess pain, irritation and discomfort measured by asking patients about their experience using the catheter using a questionnaire.

Participants will be catheterized with either a CytaCoat Foley catheter or an uncoated silicone catheter, for a maximum of 24 hrs. After removal of the catheter, participants will be asked to assess if they experienced any pain, irritation and discomfort measured with the Numerical Rating Scale (NRS) (0-10). A similar assessment will be performed 7-10 days after removal of the catheter. In addition, the healthcare personnel will be asked to assess the functionality of the coated catheter with the NRS scale (0-10), using a questionnaire. Urine samples will be taken before and after catheterization and evaluated through quantification.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-19
• Study Start: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-05
• Primary Completion: 2024-09-26
• Study Completion: 2024-09-26
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-07

Recruitment & Eligibility

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

Inclusion Criteria

• Will be undergoing a TUR-B procedure.
• Able to give informed consent by signing and dating the written informed consent document acknowledging their desire to participate in the study.
• Adults, age 18 to 84 years.
• Require insertion of a size 12, 14, 16, 18 or 20 French Foley catheter after TUR-B surgery.
• Be able to understand and comply with the information given in the Patient Consent Form.

Exclusion Criteria

• Vulnerable subjects such as children, pregnant or breastfeeding women, or potentially immune-compromised subjects.
• Unable to provide informed consent.
• Has a known bacteriuria or a current urinary tract infection.
• Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy.
• Has an ongoing antibiotic therapy.
• Cannot accommodate a size 12, 14, 16, 18 or 20 Fr Foley catheter or requires a Thiemann tip Foley catheter.
• Previous enrolment in the present study.
• Simultaneous participation in another clinical study that may impact the primary endpoint.
• Severe non-compliance to protocol as judged by the PI.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uncoated silicone Foley catheter	Drainage of the bladder by indwelling Foley catheter	Uncoated silicone Foley catheter will be randomized 1:1 (15 patients in each arm), to patients in need of catheterization for up to 24 hrs.
CytaCoat LIP Foley catheter	Drainage of the bladder by indwelling Foley catheter	CytaCoat LIP Foley catheters will be randomized 1:1 (15 patients in each arm), to patients in need of catheterization for up to 24 hrs.

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	1 - 10 days	Adverse events (AEs) and serious adverse events (SAEs) will be assessed, which are further divided into adverse device effects (ADEs) and serious ADEs (SADEs).

Secondary Outcome Measures

Name	Time	Method
Assessment of the overall performance of the CytaCoat LIP Foley catheter	1 - 10 days	The functionality of the coated catheter will be assessed by a responsible nurse/physician with the NRS scale (0-10) using questionnaires.

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden