CClinicalTrials.gg
Status unknownNCT02007980Updated May 17, 2022

Indwelling Stent Discoloration Project

An observational study in Urologic Injuries, Disorder of Urinary Stent and Kidney Calculi, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by University of British Columbia · Observational

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
70
Ages
19 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Urologic Injuries
  • Disorder of Urinary Stent
  • Kidney Calculi
  • Urinary Tract Obstruction Due to Specified Cause
  • Hydronephrosis

Keywords

  • urological problems
  • indwelling urologic stent
  • kidney stone disease
  • urinary system obstruction
  • hydronephrosis
  • ureteral damage
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Patient with indwelling ureteral stent due to urologic indication.

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

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
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
70 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with indwelling ureteral stent

    Patients with existing indwelling ureteral stent, no additional treatment

05

What researchers measure

Primary outcomes

  1. stent encrustation

    Conditioning film components and encrustation

    Time frame: at stent removal

Secondary outcomes

  1. characterize the components that discolour the Percuflex material

    Time frame: bench top testing of stents

  2. Bacterial Adhesion, Colonization, and Biofilm formation

    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

    Time frame: at 4, 24, and 48 hours post stent removal

06

Study locations

1 site
  • Vancouver General Hospital
    Vancouver, British Columbia, Canada
07

Registry details

Key details

Study ID
NCT02007980
Lead sponsor
University of British Columbia
Collaborators
Vancouver General Hospital
Responsible party
Ben Chew, MD (Associate Professor, University of British Columbia) — Principal investigator
First posted
Dec 11, 2013
Start date
Dec 2013
Primary completion
Sep 1, 2023 (estimated)
Completion
Sep 29, 2023 (estimated)
Last update
May 17, 2022

Study contacts

Ben Chew, MD
principal investigator · UBC/VGH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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