Urologic InjuriesNCT02007980
Indwelling Stent Discoloration Project
An observational study of Urologic Injuries and Disorder of Urinary Stent, run by University of British Columbia at 1 site in Canada.
Trial summary
The aim of this study is to identify the root cause for the significant discolouration of Boston Scientific Percuflex based stents. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Urologic Injuries, Disorder of Urinary Stent, Kidney Calculi
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to 29 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with indwelling ureteral stent due to urologic indication.
Who may be able to join
- Patient is at least 19 years of age (Vancouver, British Columbia, Canada - for Japan different age limit as applicable)
- Patient has indwelling ureteral stent
Who cannot join
- Pregnancy
- Positive Urine Culture
- Active cancer
- Recurrent urinary infections
- Gross hematuria
- Inability to provide informed consent
- Physician/Surgeon refuses to enter patient into study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- 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
- Medical subject headings
- Kidney Calculi, Hydronephrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with indwelling ureteral stent | Patients with existing indwelling ureteral stent, no additional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
stent encrustation
Conditioning film components and encrustation
Measured: at stent removal
Secondary outcomes (2)
characterize the components that discolour the Percuflex material
Measured: bench top testing of stents
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
Measured: at 4, 24, and 48 hours post stent removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion1 Sep 2023 (estimated)
- Study completion29 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic InjuriesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Vancouver General Hospital
- Responsible party
- Principal investigator, Ben Chew, MD, University of British Columbia
- Investigators
- Ben Chew, MD, Principal investigator, UBC/VGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02007980
- Sponsor's protocol ID
- H13-02715
- Status last verified
- May 2022
- First submitted
- 12 Nov 2013
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Underlying Factors That Cause Ureteral Stent Discoloration in Japanese and Canadian Ureteral Stents
- ClinicalTrials.gov ID
- NCT02007980
- Acronym / sponsor ID
- H13-02715
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Vancouver General Hospital
- Study start
- Dec 2013
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 29 Sep 2023 (estimated)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to identify the root cause for the significant discolouration of Boston Scientific Percuflex based stents.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with indwelling ureteral stent | – | –Patients with existing indwelling ureteral stent, no additional treatment |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with indwelling ureteral stent due to urologic indication.
Key inclusion criteria (2 listed)
- Patient is at least 19 years of age (Vancouver, British Columbia, Canada - for Japan different age limit as applicable)
- Patient has indwelling ureteral stent
Key exclusion criteria (7 listed)
- Pregnancy
- Positive Urine Culture
- Active cancer
- Recurrent urinary infections
- Gross hematuria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
stent encrustation
Time frame: at stent removal
Conditioning film components and encrustation
2 secondary outcomes
characterize the components that discolour the Percuflex material
Time frame: bench top testing of stents
Bacterial Adhesion, Colonization, and Biofilm formation
Time frame: at 4, 24, and 48 hours post stent removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Chew, MD principal investigator
UBC/VGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Injuries and Disorder of Urinary Stent, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stent encrustation (time frame: at stent removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022; AzTrials last refreshed its copy on 27 Oct 2026.