NCT01107249

A Trial of Esophageal and Gastric Stenting for Leak or Perforation

A Phase II Trial of Esophageal and Gastric Stenting for Leak or Perforation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Long term follow-up of patients treated for esophageal fistulas with a newer occlusive self-expanding covered metal stents compared to traditional stents.

Detailed description

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.

Conditions

• Esophageal or Gastric Perforations
• Esophageal or Gastric Leaks

Interventions

Type	Name	Description
DEVICE	Boston Scientific Ultraflex or Wallstent stents	Stent used to maintain luminal patency in esophageal strictures and occlude esophageal fistulas to reduce gastric leaks, perforations and/or fistulas.

Timeline

• Start date: 2010-05-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2010-04-20
• Last updated: 2016-03-17

Locations

1 site across 1 country: United States