Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision. (CBE-001-SEOS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, South West Sydney Local Health District
ClinicalTrials.gov Identifier:
NCT01554280
First received: March 11, 2012
Last updated: December 3, 2013
Last verified: December 2013

March 11, 2012
December 3, 2013
January 2012
January 2013   (final data collection date for primary outcome measure)
Improvement in Stricture Formation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01554280 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision.
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.

The purpose of this study is to investigate whether preventative placement of a removable oesophageal stent reduces the rate of scar tissue, or stricture formation after removing the precancerous or early cancerous Barrett's mucosa by Endoscopic Mucosal Resection (EMR). The stent will be placed 10-14 days after initial EMR. The stent will then be removed 8 weeks later by repeat Endoscopy. Patients will be followed up weekly following insertion of the oesophageal stent.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Constriction, Pathological
Device: Fully coated, removable , self-expanding oesophageal stent
Insertion of the fully coated, removable, self-expanding oesophageal stent for the prevention of oesophageal strictures.
Experimental: Oesophageal Stents
Patients enrolled will receive a fully coated, removable, self-expanding oesophageal stent.
Intervention: Device: Fully coated, removable , self-expanding oesophageal stent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
January 2014
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with short segment Barrett's Oesophagus with high grade dysplasia or early cancer, having circumferential EMR to achieve complete Barrett's excision.
  • Aged 18-75 years old
  • Biopsy proven to be Barretts with HGD or EAC
  • The absence or lymph node involvement
  • Short segment <3cm of Barretts Oesophagus.

Exclusion Criteria:

  • Women who are pregnant and the human foetus
  • Children and/or young people <18 years
  • People with an intellectual or mental impairment.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01554280
CBE-001-SEOS
No
Professor Michael Bourke, South West Sydney Local Health District
South West Sydney Local Health District
Not Provided
Principal Investigator: Michael Bourke, MBBS Sydney WAHS
South West Sydney Local Health District
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP