Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000586617
Ethics application status
Approved
Date submitted
27/09/2005
Date registered
4/10/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Trial Of Barretts Ablation: YAG Laser vs Argon Plasma Coagulation
Scientific title
A Randomised Trial Comparing the efficacy of YAG Laser Contact Ablation against Argon Plasma Coagulation in ablating Barretts Oesophagus.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Barrets Oesophagus 713 0
Condition category
Condition code
Oral and Gastrointestinal 790 790 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Maximum of 6 ablation treatment sessions per patient, each separated by one month. Follow up at 6 weeks, 6 months and 12 months after ablation therapy completed.
Intervention code [1] 683 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1008 0
Surface area ablated
Timepoint [1] 1008 0
At 6 weeks, 6 months and 12 months following completion of ablation
Primary outcome [2] 1009 0
Buried gland rates
Timepoint [2] 1009 0
At 6 weeks, 6 months and 12 months following completion of ablation
Secondary outcome [1] 1899 0
Complications
Timepoint [1] 1899 0
During the ablation period and at 6 weeks, 6 months and 12 months post ablation.
Secondary outcome [2] 1900 0
Biomarker reversibility
Timepoint [2] 1900 0
At 6 weeks, 6 months and 12 months.

Eligibility
Key inclusion criteria
Barretts 3 - 10cm length.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes until intervention assigned
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random shuffling of sealed allocation envelopes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 875 0
Other
Name [1] 875 0
Local Grant
Country [1] 875 0
Primary sponsor type
Hospital
Name
University of Melbourne Department of Surgery, Austin Hospital
Address
Country
Australia
Secondary sponsor category [1] 741 0
None
Name [1] 741 0
N/A
Address [1] 741 0
Country [1] 741 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2160 0
Austin Hospital
Ethics committee address [1] 2160 0
Ethics committee country [1] 2160 0
Australia
Date submitted for ethics approval [1] 2160 0
Approval date [1] 2160 0
Ethics approval number [1] 2160 0

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

Contacts
Principal investigator
Name 35111 0
Address 35111 0
Country 35111 0
Phone 35111 0
Fax 35111 0
Email 35111 0
Contact person for public queries
Name 9872 0
Ahmad Aly
Address 9872 0
Department of Surgery
Austin Hospital
Level 8
Kance Townsend Building (LTB)
Studley Rd
Heidelberg VIC 3084
Country 9872 0
Australia
Phone 9872 0
+61 3 94965000
Fax 9872 0
Email 9872 0
aaly@unimelb.edu.au
Contact person for scientific queries
Name 800 0
Ahmad Aly
Address 800 0
Department of Surgery
Austin Hospital
Level 8
Kance Townsend Building (LTB)
Studley Rd
Heidelberg VIC 3084
Country 800 0
Australia
Phone 800 0
+61 3 94965000
Fax 800 0
Email 800 0
aaly@unimelb.edu.au

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.