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NCT02007980 Clinical Trial

Indwelling Stent Discoloration Project

Kidney Calculi Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02007980
Other study ID # H13-02715
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 2013
Est. completion date September 29, 2023

Study information
Verified date May 2022
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70
Est. completion date September 29, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Canada Vancouver General Hospital Vancouver British Columbia

Sponsors (2)
Lead Sponsor Collaborator
University of British Columbia Vancouver General Hospital

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary stent encrustation Conditioning film components and encrustation at stent removal
Secondary characterize the components that discolour the Percuflex material bench top testing of stents
Secondary 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 at 4, 24, and 48 hours post stent removal
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