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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01554280




Registration number
NCT01554280
Ethics application status
Date submitted
11/03/2012
Date registered
14/03/2012
Date last updated
23/03/2021

Titles & IDs
Public title
Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision.
Scientific title
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.
Secondary ID [1] 0 0
CBE-001-SEOS
Universal Trial Number (UTN)
Trial acronym
CBE-001-SEOS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Constriction, Pathological 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Fully coated, removable , self-expanding oesophageal stent

Experimental: Oesophageal Stents - Patients enrolled will receive a fully coated, removable, self-expanding oesophageal stent.


Treatment: Devices: Fully coated, removable , self-expanding oesophageal stent
Insertion of the fully coated, removable, self-expanding oesophageal stent for the prevention of oesophageal strictures.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Improvement in Stricture Formation
Timepoint [1] 0 0
12 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant and the human foetus
* Children and/or young people <18 years
* People with an intellectual or mental impairment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Professor Michael Bourke
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Bourke, MBBS
Address 0 0
WSLHD
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01554280