Indwelling Stent Discoloration Project

Sponsor

University of British Columbia (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02007980

Collaborator

Vancouver General Hospital (Other)

Enrollment

Location

117.9

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urologic Injuries Disorder of Urinary Stent Kidney Calculi Urinary Tract Obstruction Due to Specified Cause Hydronephrosis

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

Study Type:

Observational

Anticipated Enrollment :

70 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2013

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Sep 29, 2023

Arms and Interventions

Arm	Intervention/Treatment
Patients with indwelling ureteral stent Patients with existing indwelling ureteral stent, no additional treatment

Outcome Measures

Primary Outcome Measures

stent encrustation [at stent removal]
Conditioning film components and encrustation

Secondary Outcome Measures

characterize the components that discolour the Percuflex material [bench top testing of stents]
Bacterial Adhesion, Colonization, and Biofilm formation [at 4, 24, and 48 hours post stent removal]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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