Trials / Completed
CompletedNCT02238847
Pre-operative Biliary SEMS RCT During Neoadjuvant Therapy
Randomized Controlled Trial Comparing Covered and Uncovered Biliary Self Expanding Metal Stents (SEMS) for Pre-operative Drainage During Neoadjuvant Therapy in Patients With Pancreatic Cancer
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 119 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | WallFlex™ Biliary RX Fully Covered/Uncovered Stent System | Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System |
Timeline
- Start date
- 2015-03-24
- Primary completion
- 2018-02-21
- Completion
- 2018-04-10
- First posted
- 2014-09-12
- Last updated
- 2020-02-17
- Results posted
- 2020-02-17
Locations
9 sites across 6 countries: United States, Belgium, Canada, Italy, Japan, South Korea
Source: ClinicalTrials.gov record NCT02238847. Inclusion in this directory is not an endorsement.