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A Trial of Esophageal and Gastric Stenting for Leak or Perforation

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

Summary

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

Conditions

Esophageal or Gastric Perforations

Intervention

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

Status

Not yet recruiting

Source

The Methodist Hospital System

Results (where available)

View Results

Links

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

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Medical and Biotech [MESH] Definitions

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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.

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