Long Term Barrett's Endoscopic Mucosal Resection Study | NCT02200250

Studies
Long Term Barrett's Endoscopic Mucosal Resection Study

NCT02200250

Sponsor

Professor Michael Bourke

Status

Withdrawn

Last Update Posted

Jul 3, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Barretts Esophagus

Interventions

Not provided

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study abandoned

Expanded Access Info

Start Date

Oct 1, 2021Estimated

Primary Completion Date

Oct 2022Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Jul 17, 2014

First Submission Date that Met QC Criteria

Jul 24, 2014

First Posted Date

Jul 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2023

Last Update Posted Date

Jul 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health DistrictSponsor-Investigator

Lead Sponsor

Professor Michael BourkeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Analysis of long term outcomes of patients undergoing endoscopic mucosal resection for Barrett's oesophagus with high grade dysplasia and/or early intramucosal carcinoma (IMC).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Post Barretts Excision		Patients who have undergone an EMR for Barretts Oesophagus

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reviewing patients symptoms following resection	Patients will be contacted via phone and will be required to answer questions over the phone. Health questionnaires may also be sent at the patients request to complete and post back.	up to 3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or over
Have or have had Barrett's Oesophagus

Exclusion Criteria:

Do not have Barrett's Oesophagus
Have not had Barrett's Oesophagus resected at Westmead Hospital

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Patients who have or have had Barrett's Oesophagus with high grade dysplasia or adenocarcinoma.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael J Bourke, MBBS	Western Sydney Local Health District	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Westmead Endoscopy Unit		Westmead	New South Wales	2145	Australia

Condition Browse Module

MeSH Terms

ID	Term
D001471	Barrett Esophagus

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided