NCT02261623

Brief Summary

The purpose of this study is to document stent functionality and practice patterns in Canada pertaining to indications for use and stent type selection for self-expanding biliary metal stents (SEMS) when used per standard of practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
415

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

12 active sites

Status
completed

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

October 7, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

March 19, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2016

Completed
Last Updated

January 6, 2020

Status Verified

January 1, 2020

Enrollment Period

1 year

First QC Date

October 7, 2014

Last Update Submit

January 3, 2020

Conditions

Biliary Strictures

Outcome Measures

Primary Outcomes (1)

  • Stent Functionality

    Stent functionality defined as absence of unscheduled biliary reintervention for the management of biliary obstructive symptoms during study stent indwell

    24 Months

Secondary Outcomes (10)

  • Serious adverse events

    24 Months

  • Indication for stent placement

    12 Months

  • Stent types

    12 Months

  • Biliary obstructive symptoms

    24 Months

  • Technical success at placement

    24 Months

  • +5 more secondary outcomes

Study Arms (4)

Palliation

Palliative treatment of biliary strictures produced by malignant neoplasms, no intended surgery

Device: WallFlex™ Biliary RX Fully Covered Stent System RMVDevice: WallFlex™ Biliary RX Partially Covered Stent SystemDevice: WallFlex™ Biliary RX Uncovered Stent System

Curative intent surgery

Palliative treatment of biliary strictures produced by malignant neoplasms, prior to curative intent surgery, with or without neoadjuvant therapy

Device: WallFlex™ Biliary RX Partially Covered Stent SystemDevice: WallFlex™ Biliary RX Uncovered Stent System

Benign biliary strictures

Treatment of benign biliary strictures

Device: WallFlex™ Biliary RX Fully Covered Stent System RMVDevice: WallFlex™ Biliary RX Partially Covered Stent SystemDevice: WallFlex™ Biliary RX Uncovered Stent System

Other indication

Other indication

Device: WallFlex™ Biliary RX Partially Covered Stent SystemDevice: WallFlex™ Biliary RX Uncovered Stent System

Interventions

WallFlex™ Biliary RX Fully Covered Stent System RMVDEVICE

For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures

Benign biliary stricturesPalliation
WallFlex™ Biliary RX Partially Covered Stent SystemDEVICE

For use in the palliative treatment of biliary strictures produced by malignant neoplasms.

Benign biliary stricturesCurative intent surgeryOther indicationPalliation
WallFlex™ Biliary RX Uncovered Stent SystemDEVICE

For use in the palliative treatment of biliary strictures produced by malignant neoplasms.

Benign biliary stricturesCurative intent surgeryOther indicationPalliation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who have been diagnosed with a blockage of the bile duct which may be caused by a benign or malignant biliary stricture.

You may qualify if:

  • Subject indicated for biliary metal stent placement per local standard of practice
  • Age 18 or older
  • Willing and able to comply with study procedures and follow-up schedule
  • Willing and able to provide written informed consent to participate in study

You may not qualify if:

  • Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
  • Subjects who the investigator deems at risk for device or procedure related complications per the Directions for Use (DFU)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Peter Lougheed Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, T6G 2P4, Canada

Location

Providence Health - St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Victoria General Hospital

Victoria, British Columbia, V8R 1J8, Canada

Location

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Oakville-Trafalgar Memorial Hospital

Oakville, Ontario, L6J 3L7, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Hopital Charles Le Moyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

CHUM - Hopital Saint-Luc

Montreal, Quebec, H2X 3J4, Canada

Location

CHUS Hotel Dieu

Sherbrooke, Quebec, J1K 2R1, Canada

Location

Study Officials

  • Gurpal Sandha, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2014

First Posted

October 10, 2014

Study Start

March 19, 2015

Primary Completion

March 31, 2016

Study Completion

March 31, 2016

Last Updated

January 6, 2020

Record last verified: 2020-01

Locations

CA(12)