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
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

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

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