Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision. (CBE-001-SEOS)
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|ClinicalTrials.gov Identifier: NCT01554280|
Recruitment Status : Completed
First Posted : March 14, 2012
Last Update Posted : December 5, 2014
|Condition or disease||Intervention/treatment||Phase|
|Constriction, Pathological||Device: Fully coated, removable , self-expanding oesophageal stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fully, Coated, Removable, Self-expanding Oesophageal Stents for the Prevention of Oesophageal Stricture Following Endoscopic Mucosal Resection of Short Segment Barrett's With High Grade Dysplasia and Early Cancer.|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2014|
Experimental: Oesophageal Stents
Patients enrolled will receive a fully coated, removable, self-expanding oesophageal stent.
Device: Fully coated, removable , self-expanding oesophageal stent
Insertion of the fully coated, removable, self-expanding oesophageal stent for the prevention of oesophageal strictures.
- Improvement in Stricture Formation [ Time Frame: 12 weeks ]Initial evaluation of Dysphagia score which is used to assess the stricture formation prior to EMR. Followed by weekly phone calls to assess ability to swallow liquids and food.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01554280
|Australia, New South Wales|
|Westmead, New South Wales, Australia, 2145|
|Principal Investigator:||Michael Bourke, MBBS||Sydney WAHS|