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):

Dr Michael Bourke, South West Sydney Local Health District

ClinicalTrials.gov Identifier:

NCT01554280

First received: March 11, 2012

Last updated: November 27, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 11, 2012

Last Updated Date

November 27, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01554280 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision.

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Constriction, Pathological

Intervention ^ICMJE

Device: Fully coated, removable , self-expanding oesophageal stent

Insertion of the fully coated, removable, self-expanding oesophageal stent for the prevention of oesophageal strictures.

Study Arm (s)

Experimental: Oesophageal Stents

Patients enrolled will receive a fully coated, removable, self-expanding oesophageal stent.

Intervention: Device: Fully coated, removable , self-expanding oesophageal stent

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Australia

Administrative Information

NCT Number ^ICMJE

NCT01554280

Other Study ID Numbers ^ICMJE

CBE-001-SEOS

Has Data Monitoring Committee

Responsible Party

Dr Michael Bourke, South West Sydney Local Health District

Study Sponsor ^ICMJE

South West Sydney Local Health District

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael Bourke, MBBS

Sydney WAHS

Information Provided By

South West Sydney Local Health District

Verification Date

November 2012

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

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