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PTFE Stents for Treatment of Malignant Biliary Strictures

NCT03763214 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-12-04

No results posted yet for this study

Summary

In this randomized trial two two self-expanding metal stents (SEMS) for treatment of malignant biliary strictures are investigated.

A newly developed PTFE (Polytetrafluorethylen) (Teflon) stent is tested versus standard covered metal stents. PFTE (Teflon) coating promises improved formability over standard silicone-coated stents, easier removal through the soft surface, and significantly reduced tumor growth through the impermeable surface.

Conditions

Interventions

DEVICE

Stenting with PTFE-coated stent (HILZO)

Placing a metal stent in the biliary tract by duodenoscopy

Sponsors & Collaborators

  • Robert Bosch Medical Center

    collaborator OTHER

  • Klinikum Stadt Hanau

    collaborator OTHER

  • Johannes Vermehren

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2020-03-31
Completion
2020-09-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT03763214 on ClinicalTrials.gov