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Endo-biliary Laser Excision of Biliary Stenoses

NCT02118493 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2015-12-03

No results posted yet for this study

Summary

The biliary system normally empties into the intestines, however, some patients have biliary system narrow areas ("stenosis") that prevent the bile to drain normally. These may be related to an underlying disease or previous surgery. Patients with this problem usually require tubes to be inserted into the biliary system to drain bile into a bag outside of their body, impacting their quality of life.

The purpose of this research study is to use a laser device to try to re-open the biliary drainage system.

Conditions

  • Biliary Tract Disease
  • Bile Duct Obstruction

Interventions

DEVICE

Benign Biliary Stenosis, Laser

Single use of laser to attempt excision of biliary ductal tissue causing stenosis.

Sponsors & Collaborators

  • Spectranetics Corporation

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Beau Toskich, MD · University of Florida Dept of Interventional Radiology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-07-31
Completion
2017-05-31

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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 NCT02118493 on ClinicalTrials.gov