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

NCT06242600 | Completed Early Phase 1

• 2 other identifiers: CIV-23-03-042616CYTA-FOL-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

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

  1 - 10 days

Secondary Outcomes (1)

• Assessment of the overall performance of the CytaCoat LIP Foley catheter

  1 - 10 days

Other Outcomes (2)

• Exploratory assessment of bacterial culture of urine samples

  1 - 48 hours

• Exploratory assessment of patient user experience of the CytaCoat LIP Foley catheter

  1 - 10 days

Study Arms (2)

CytaCoat LIP Foley catheter

EXPERIMENTAL

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.

Device: Drainage of the bladder by indwelling Foley catheter

Uncoated silicone Foley catheter

OTHER

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.

Device: Drainage of the bladder by indwelling Foley catheter

Interventions

Drainage of the bladder by indwelling Foley catheter 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.

Also known as: CytaCoat LIP Foley catheter

CytaCoat LIP Foley catheter; Uncoated silicone Foley catheter

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CytaCoat AB: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Study Officials

• Anders Andreasson, MD

  Sahlgrenska University Hospital, Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The healthcare practitioner placing the catheter will know the allocation (whether it is a CytaCoat LIP Foley catheter or the comparator) but the participant will not know which catheter they have received. The healthcare practitioner removing the catheter will not know the allocation. Urine samples that are analysed will not state which arm the participant is in.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized 1:1 to CytaCoat LIP Foley catheter / uncoated silicone Foley catheter (15 patients in each arm).

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 5, 2024
• Study Start: January 29, 2024
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)