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

This study has been withdrawn prior to enrollment.
(No participants enrolled for more than 1 year.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01301495
First Posted: February 23, 2011
Last Update Posted: June 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
M.I.Tech Co., Ltd.
Information provided by (Responsible Party):
Michel Kahaleh, Weill Medical College of Cornell University
  Purpose
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

Condition Intervention Phase
Esophageal Cancer Device: HANAROSTENT TM covered Esophageal Stent Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus

Resource links provided by NLM:


Further study details as provided by Michel Kahaleh, Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Palliation assessment based on Dysphagia Scores [ Time Frame: 2 years ]
    To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;


Secondary Outcome Measures:
  • Assessment of Complications and MD Anderson Dysphagia Score [ Time Frame: 2-4 years ]
    To determine whether it is non-inferior in efficacy and safety to the esophageal stents currently available at UVa with minimal complications and improvement of symptoms


Enrollment: 0
Study Start Date: November 2010
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HANAROSTENT covered Esophageal Stent 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
Other Name: HANAROSTENT

Detailed Description:

The incidence of esophageal cancer is increasing, and despite advances in treatment, the prognosis is still very poor [1-4]. At presentation, between 50-60 % of patients have unresectable disease [5,6]. For these patients, palliation is the goal with a particular focus on the relief of dysphagia, which is the major etiology of morbidity [5,6]. Presently, Self expanding metal stent (SEMS) have become the treatment of choice for dysphagia associated with unresectable esophageal and GE junction malignancies.

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

The objectives are:

  1. To evaluate if the newly fully covered metal stent , HANAROSTENT can provide adequate palliation of cancerous lesions of the esophagus;
  2. To determine whether it is non-inferior in efficacy and safety to the esophageal stents currently available at UVa with minimal complications and improvement of symptoms
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inoperable malignant obstruction of the esophageal or gastric cardia
  • Malignant fistula between the esophagus ans respiratory tree
  • Recurrent cancer after prior radiation

Exclusion Criteria:

  • Patient unstable for endoscopic procedure
  • Previous esophageal stenting
  • Tumor growth within 2 cm of the upper esophageal sphincter
  • Pregnant women (self reported, no pregnancy test will be done per protocol)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01301495


Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
M.I.Tech Co., Ltd.
Investigators
Principal Investigator: Michel Kahaleh, M.D. Weill Medical College of Cornell University
  More Information

Responsible Party: Michel Kahaleh, Chief, Advanced Endoscopy, Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01301495     History of Changes
Other Study ID Numbers: 14989
First Submitted: February 17, 2011
First Posted: February 23, 2011
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Michel Kahaleh, Weill Medical College of Cornell University:
Esophageal Cancer, Malignant, Dysphagia, Esophagus, Cancer

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases