Sharklet Catheter Study

April 4, 2017 updated by: Dirk Lange, University of British Columbia

Randomized Controlled Trial for the Early Clinical Experience and Evaluation of the Radiance Clear Sharklet Silicone Foley Catheter

The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.

Study Type

Interventional

Enrollment (Anticipated)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • The Stone Centre, VGH/UBC
        • Sub-Investigator:
          • Ben Chew, MD
        • Principal Investigator:
          • Dirk Lange, PhD
        • Sub-Investigator:
          • Mark Nigro, MD
        • Contact:
        • Sub-Investigator:
          • Alex Kavanagh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient requires a chronic indwelling Foley catheter for at least 14 days. Catheters will not remain indwelling greater than 30 days at a time
  • Patient is more than 19 years of age
  • Patient is able to give informed consent
  • Patient is able to attend follow-up sessions

Exclusion Criteria:

  • Patient is less than 19 years of age
  • Patient is pregnant
  • Patient with a known allergy to silicone
  • Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter
  • Patient unable to accommodate the catheter
  • Patient has an active urinary tract infection (UTI) or other diagnosed infection that is untreated. Once the infection has been treated, the patient is eligible for study.
  • Patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period
  • Patient has uncontrolled fecal incontinence (uncontrolled stool/poop passage)
  • Patient is unable to feel and/or communicate their symptoms
  • Informed consent is unable to be obtained
  • Patient is unable or unwilling to comply with the study follow-up schedule
  • Patient has a medical condition or disorder that would limit life expectancy to less than 30 days or that may cause non-compliance with the protocol or confound the data analysis
  • Any other reason that if in the opinion of the investigator would make the patient unsuitable for enrollment in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A: Sharklet Catheter for 2 weeks first

Arm A will have catheters inserted according to the schedule below:

  1. Sharklet catheter inserted for 2 weeks
  2. Standard catheter inserted for 2 weeks
  3. Sharklet catheter inserted for 4 weeks
  4. Standard catheter inserted for 4 weeks
Device: Radiance™ Clear Sharklet® Silicone Foley Catheter
Device: Silicone Foley Catheter
Other Names:
  • Standard of care
Active Comparator: Group B: Sharklet Catheter for 4 weeks first

Arm B will have catheters inserted according to the schedule below:

  1. Sharklet catheter inserted for 4 weeks
  2. Standard catheter inserted for 4 weeks
  3. Sharklet catheter inserted for 2 weeks
  4. Standard catheter inserted for 2 weeks
Device: Radiance™ Clear Sharklet® Silicone Foley Catheter
Device: Silicone Foley Catheter
Other Names:
  • Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)
Time Frame: 12 weeks
Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.
12 weeks
Number of symptomatic Urinary tract infections (UTIs) determined by urine culture
Time Frame: 12 weeks
Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Crustation
Time Frame: 12 weeks
Incidence of catheter obstruction/encrustation requiring removal
12 weeks
Incidence of Discomfort
Time Frame: 12 weeks
Incidence of significant discomfort/pain requiring removal
12 weeks
Delay to symptomatic CA-SUTI
Time Frame: 12 weeks
Delay to symptomatic catheter-associated symptomatic urinary tract infection (CA-SUTI)
12 weeks
Incidence of bacteria
Time Frame: 12 weeks
Incidence of bacteremia following CA-SUTI
12 weeks
Surface analysis of the type of bacteria found on each catheter
Time Frame: 12 weeks
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of bacterial colonization
12 weeks
Surface analysis of the amount of encrustation
Time Frame: 12 weeks
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of encrustation
12 weeks
Surface analysis of the biofilm formation
Time Frame: 12 weeks
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of biofilm formation
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Dirk Lange, PhD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

February 1, 2019

Study Completion (Anticipated)

February 1, 2019

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

January 27, 2016

First Posted (Estimate)

February 1, 2016

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H15-03435

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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