Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-29 @ 8:36 PM
Study NCT ID:
NCT01301495
Status:
WITHDRAWN
Last Update Posted:
2015-06-03
First Post:
2011-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus
Sponsor:
Weill Medical College of Cornell University
Organization:
Study Overview
Official Title:
Prospective Evaluation of a New Covered Metal Stent for Malignant Lesions of the Esophagus
Status:
WITHDRAWN
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants enrolled for more than 1 year.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: