ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02261623
Date of registration:	07/10/2014
Prospective Registration:	Yes
Primary sponsor:	Boston Scientific Corporation
Public title:	Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry
Scientific title:	Prospective, Multi-Center All-Comer Biliary Canadian WallFlex Registry
Date of first enrolment:	March 19, 2015
Target sample size:	415
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02261623
Study type:	Observational [Patient Registry]
Study design:
Phase:

Countries of recruitment
Canada

Contacts

Name:	Gurpal Sandha, MD
Address:
Telephone:
Email:
Affiliation:	University of Alberta

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Biliary Strictures

Intervention(s)

Device: WallFlex™ Biliary RX Fully Covered Stent System RMV

Device: WallFlex™ Biliary RX Partially Covered Stent System

Device: WallFlex™ Biliary RX Uncovered Stent System

Primary Outcome(s)

Stent Functionality [Time Frame: 24 Months]

Secondary Outcome(s)

Stent types [Time Frame: 12 Months]

Biliary obstructive symptoms [Time Frame: 24 Months]

Indication for stent placement [Time Frame: 12 Months]

Resolution of the indication for stent placement [Time Frame: 24 Months]

Serious adverse events [Time Frame: 24 Months]

Time to recurrence of original stricture [Time Frame: 24 Months]

Technical success at removal [Time Frame: 24 Months]

Technical success at placement [Time Frame: 24 Months]

Neoadjuvant therapy [Time Frame: 24 Months]

Stricture resolution [Time Frame: 24 Months]

Secondary ID(s)

90921899

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.