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NCT01301495 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL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