A Trial of Esophageal and Gastric Stenting for Leak or Perforation

2014-07-23 21:09:29 | BioPortfolio


This study is written to evaluate our experience treating esophageal fistulas with occlusive self-expanding covered metal stents. The long-term outcomes of patients treated with this new type of stent are as yet unknown. The differences between these stents is also unknown, as well as the ease of removal, efficacy, and/or placement. The intent of this study is not to determine which stent is better, but to merely evaluate the use of both. With this in mind, there will be no randomization of stent use, nor will there be restrictions on which stent may be used in which setting. This will be left to the judgment of the clinical placing the stent.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Esophageal or Gastric Perforations


Alveolus Alimaxx-e stent, Boston Scientific Ultraflex or Wallstent stents


Not yet recruiting


The Methodist Hospital System

Results (where available)

View Results


Published on BioPortfolio: 2014-07-23T21:09:29-0400

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Medical and Biotech [MESH] Definitions

Stents that are covered with materials that are embedded with chemicals that are gradually released into the surrounding milieu.

City located in Massachusetts.

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Devices that provide support for tubular structures that are being anastomosed or for body cavities during skin grafting.

The new and thickened layer of scar tissue that forms on a PROSTHESIS, or as a result of vessel injury especially following ANGIOPLASTY or stent placement.

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