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

NCT ID: NCT06242600

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-29
• Study Completion Date: 2024-09-26

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

CytaCoat LIP 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.

Group Type: EXPERIMENTAL

Drainage of the bladder by indwelling Foley catheter

Intervention Type: DEVICE

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.

Uncoated silicone 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.

Group Type: OTHER

Drainage of the bladder by indwelling Foley catheter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

CytaCoat LIP Foley catheter

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CytaCoat AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Andreasson, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital, Department of Urology

Locations

Sahlgrenska University Hospital

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

CYTA-FOL-1

Identifier Type: OTHER

Identifier Source: secondary_id

CIV-23-03-042616

Identifier Type: -

Identifier Source: org_study_id