A Phase 2 interventional study of Boston Scientific Ultraflex or Wallstent stents in Esophageal or Gastric Perforations and Esophageal or Gastric Leaks, sponsored by The Methodist Hospital Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-17.
Sponsored by The Methodist Hospital Research Institute · Phase 2, Interventional, and Treatment
Long term follow-up of patients treated for esophageal fistulas with a newer occlusive self-expanding covered metal stents compared to traditional stents.
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.
The Methodist Hospital Research Institute is the lead sponsor of 160 studies on the registry; 60 are open to participants now.
Of its 26 completed or terminated interventional studies of FDA-regulated products, 16 (62%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All subjects receive a stent of surgeons choice from selected stents.
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.
Also known as: Ultraflex, ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
Safety of esophageal stenting by conducting an Omnipaque swallow and by the success of leakage stops and fistula healing.
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
Time frame: 15 - 30 days
Efficacy of esophageal stenting by the success of leakage stops and fistula healing.
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
Time frame: 15 - 30 days
A 30 day duration of stent placement and the relation to the healing esophagus
By results from all procedures as reported by the surgeon conducting the stenting in relationship to difficulty and/or complications, as well as patient tolerability. Evaluation of the healing process of the esophagus within first 30 days with the capability of its removal procedure. When the esophagus can be sealed and any contamination drained, the stents have successfully provided coverage to allow healing of the esophageal wall.
Time frame: 30 days
An institutional protocol for stent management
Results will be considered for assessing and instituting an institutional protocol to become the standard of care for future patient situations.
Time frame: 1 year
Plan to share: No — No plan to share data at this time. The PI has relocated to another institution and closed the IDE.
No publications or documents are linked to this record.
The record gives a start of May 2010, a primary completion of Oct 2014 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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