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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01554280

Acronym

CBE-001-SEOS

Enrollment

Registered

2012-03-14

Start date

2012-01-31

Completion date

2014-01-31

Last updated

2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constriction, Pathological

Keywords

Stricture, Dysphagia

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.

Interventions

DEVICEFully coated, removable , self-expanding oesophageal stent

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Improvement in Stricture Formation	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.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026