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

NCT ID: NCT01554280

Last Updated: 2021-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Constriction, Pathological

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Oesophageal Stents

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

Group Type EXPERIMENTAL

Fully coated, removable , self-expanding oesophageal stent

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fully coated, removable , self-expanding oesophageal stent

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Professor Michael Bourke

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Professor Michael Bourke

Dr Michael Bourke

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Bourke, MBBS

Role: PRINCIPAL_INVESTIGATOR

WSLHD

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Australia

References

Explore related publications, articles, or registry entries linked to this study.

Holt BA, Jayasekeran V, Williams SJ, Lee EY, Bahin FF, Sonson R, Lord RV, Bourke MJ. Early metal stent insertion fails to prevent stricturing after single-stage complete Barrett's excision for high-grade dysplasia and early cancer. Gastrointest Endosc. 2015 Apr;81(4):857-64. doi: 10.1016/j.gie.2014.08.022. Epub 2014 Oct 16.

Reference Type DERIVED
PMID: 25442084 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CBE-001-SEOS

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.