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WallFlex Pancreatic Metal Stent for Pancreatic Duct Strictures

NCT02802020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2022-11-21

Study results available
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Summary

To prospectively document the performance of a FCSEMS for treatment of pancreatic duct strictures in patients with painful chronic pancreatitis.

Conditions

  • Chronic Pancreatitis

Interventions

DEVICE

Pancreatic fully-covered self-expanding metal stent (FCSEMS)

The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Jacques Deviere, MD, PhD · ULB Erasme Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-25
Primary Completion
2021-11-24
Completion
2021-11-24
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Canada
  • India
  • Italy
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02802020 on ClinicalTrials.gov