Indwelling Stent Discoloration Project | NCT02007980

Studies
Indwelling Stent Discoloration Project

NCT02007980

Sponsor

University of British Columbia

Status

Unknown status

Last Update Posted

May 17, 2022Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Sep 1, 2023Estimated

Completion Date

Sep 29, 2023Estimated

First Submitted Date

Nov 12, 2013

First Submission Date that Met QC Criteria

Dec 5, 2013

First Posted Date

Dec 11, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2022

Last Update Posted Date

May 17, 2022Actual

Name	Class
Vancouver General Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with indwelling ureteral stent		Patients with existing indwelling ureteral stent, no additional treatment

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stent encrustation	Conditioning film components and encrustation	at stent removal

Secondary Outcomes

Measure	Description	Time Frame
characterize the components that discolour the Percuflex material		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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with indwelling ureteral stent due to urologic indication.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ben Chew, MD	UBC/VGH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vancouver General Hospital		Vancouver	British Columbia		Canada

Condition Browse Module

MeSH Terms

ID	Term
D007669	Kidney Calculi
D006869	Hydronephrosis

Ancestor Terms

ID	Term
D053040	Nephrolithiasis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided