NCT06242600

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

A Prospective Single-center Randomized Pilot Study to Evaluate the Safety and Performance of the Novel CytaCoat LIP Foley Catheter When Compared to an Uncoated Foley Catheter

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: CytaCoat AB · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Safety of the CytaCoat LIP Foley Catheter
• Tolerability of the CytaCoat LIP Foley Catheter

Interventions

Type	Name	Description
DEVICE	Drainage of the bladder by indwelling Foley catheter	Drainage of the bladder by transurethral catheterization with an indwelling Foley catheter of patients undergoing a TUR-B procedure and in need of a Foley catheter for up to 24 hrs.

Timeline

• Start date: 2024-01-29
• Primary completion: 2024-09-26
• Completion: 2024-09-26
• First posted: 2024-02-05
• Last updated: 2024-11-07

Locations

1 site across 1 country: Sweden