Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus

NCT01301495 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-06-03

No results posted yet for this study

Summary

In this study, a newly designed and FDA approved fully covered metal stents will be used to palliate 20 patients with malignant lesion of the esophagus. Dysphagia score will be assessed before and after treatment to confirm efficacy

Conditions

  • Esophageal Cancer

Interventions

DEVICE

HANAROSTENT TM covered Esophageal Stent

HANAROSTENT covered Esophageal Stent for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and or extrinsic malignant tumors only and occlusion of concurrent esophageal fistula

Sponsors & Collaborators

  • M.I.Tech Co., Ltd.

    collaborator UNKNOWN
  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Michel Kahaleh, M.D. · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

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 NCT01301495 on ClinicalTrials.gov