NCT02007980

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2013

Completed
19 days until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2023

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

9.8 years

First QC Date

November 12, 2013

Last Update Submit

May 16, 2022

Conditions

Urologic InjuriesDisorder of Urinary StentKidney CalculiUrinary Tract Obstruction Due to Specified CauseHydronephrosis

Keywords

urological problemsindwelling urologic stentkidney stone diseaseurinary system obstructionhydronephrosisureteral damage

Outcome Measures

Primary Outcomes (1)

  • stent encrustation

    Conditioning film components and encrustation

    at stent removal

Secondary Outcomes (2)

  • 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

Study Arms (1)

Patients with indwelling ureteral stent

Patients with existing indwelling ureteral stent, no additional treatment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with indwelling ureteral stent due to urologic indication.

You may qualify if:

  • Patient is at least 19 years of age (Vancouver, British Columbia, Canada - for Japan different age limit as applicable)
  • Patient has indwelling ureteral stent

You may not qualify if:

  • Pregnancy
  • Positive Urine Culture
  • Active cancer
  • Recurrent urinary infections
  • Gross hematuria
  • Inability to provide informed consent
  • Physician/Surgeon refuses to enter patient into study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Kidney CalculiHydronephrosis

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ben Chew, MD

    UBC/VGH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 12, 2013

First Posted

December 11, 2013

Study Start

December 1, 2013

Primary Completion

September 1, 2023

Study Completion

September 29, 2023

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

CA(1)