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

NCT06242600 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-07

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • CytaCoat AB

    lead INDUSTRY

Principal Investigators

  • Anders Andreasson, MD · Sahlgrenska University Hospital, Department of Urology

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-29
Primary Completion
2024-09-26
Completion
2024-09-26

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06242600 on ClinicalTrials.gov