ClinicalTrials.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this record recently (last verified May 2022), so the status shown — last known as Active, not recruiting — may be out of date.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

In context

Kidney Calculi

509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.

This study's planned enrollment of 70 is below the median of 160 across 96 observational studies indexed under Kidney Calculi.

Browse Kidney Calculi studies →

Lead sponsor

University of British Columbia is the lead sponsor of 1,339 studies on the registry; 259 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Physician/Surgeon refuses to enter patient into study
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

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

06

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

07

Study locations

1 site
  • Vancouver General Hospital
    Vancouver, British Columbia, Canada
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2013, a primary completion of Sep 2023 and a completion of Sep 2023. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 12, 2013
First posted
Dec 11, 2013
Start
Dec 2013
Primary completionEst.
Sep 1, 2023
CompletionEst.
Sep 29, 2023
Last update
May 17, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02007980
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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Discussion

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