Indwelling Stent Discoloration Project

May 16, 2022 updated by: Ben Chew, MD, University of British Columbia

Examining the Underlying Factors That Cause Ureteral Stent Discoloration in Japanese and Canadian Ureteral Stents

The aim of this study is to identify the root cause for the significant discolouration of Boston Scientific Percuflex based stents.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

The aim of this study is to identify the root cause for the significant discolouration of Boston Scientific Percuflex based stents observed in some patients, particularly those from Japan. We will also test and compare them to stents from Canadian patients. Furthermore, we will determine whether the discolouration promotes bacterial adhesion and/or encrustation of the stent.

Study Type

Observational

Enrollment (Anticipated)

70

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
        • Vancouver General Hospital

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

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with indwelling ureteral stent due to urologic indication.

Description

Inclusion Criteria:

  • Patient is at least 19 years of age (Vancouver, British Columbia, Canada - for Japan different age limit as applicable)
  • Patient has indwelling ureteral stent

Exclusion Criteria:

  • Pregnancy
  • Positive Urine Culture
  • Active cancer
  • Recurrent urinary infections
  • Gross hematuria
  • Inability to provide informed consent
  • Physician/Surgeon refuses to enter patient into 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

Cohorts and Interventions

Group / Cohort
Patients with indwelling ureteral stent
Patients with existing indwelling ureteral stent, no additional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stent encrustation
Time Frame: at stent removal
Conditioning film components and encrustation
at stent removal

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
characterize the components that discolour the Percuflex material
Time Frame: bench top testing of stents
bench top testing of stents
Bacterial Adhesion, Colonization, and Biofilm formation
Time Frame: at 4, 24, and 48 hours post stent removal
Stent pieces from the stent that has been in the patient will be exposed to bacteria and artificial urine to mimic ureter environment in order to find information on: bacterial adhesion, colonization and biofilm formation
at 4, 24, and 48 hours post stent removal

Collaborators and Investigators

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

Sponsor

University of British Columbia

Collaborators

Vancouver General Hospital

Investigators

  • Principal Investigator: Ben Chew, MD, UBC/VGH

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

December 1, 2013

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

September 29, 2023

Study Registration Dates

First Submitted

November 12, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H13-02715

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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