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Trial registered on ANZCTR


Registration number
ACTRN12607000340437
Ethics application status
Not yet submitted
Date submitted
21/06/2007
Date registered
26/06/2007
Date last updated
26/06/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
An Observer-Blinded Study to Determine the Feasibility of Pressure-Based Swedish Adjustable Gastric Band (SAGB) Adjustments in aiding weight loss
Scientific title
An Observer-Blinded Study to Determine the Feasibility of Pressure-Based Swedish Adjustable Gastric Band Adjustments in aiding weight loss
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bariatric Banding
Weight Loss 1891 0
Condition category
Condition code
Other 1986 1986 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Gastric Band adjustments are performed to vary the degree of restriction the band delivers hence allowing more or less food consumption. The adjustment is made by injection of saline into the band. The frequency of routine band adjustment is dependent on degree of weight loss.

The subject will be asked to swallow a measured amount of water, the band will be adjusted per standard hospital procedure, then another measured amount of water and one of three food or juice substances will be consumed. A pressure transducer (sensor) which is connected to the standard adjustment equipment (outside the body) will detect the pressure within the gastric band as the food is swallowed. The pressure will be recorded on a computer. The procedure may take up to 30 minutes. The measurements will be taken during one adjustment only.

The study consists of three parts, Phase one Part one assesses which substance provides the most consistent pressure pattern, Phase 1 Part 2 tests what volume provides the most consistent pressure reading. Phase 2 tests the differences and consistency in pressures within the band.

Assignment to each phase is sequential and is dependent on the preceeding number of patients enrolled.
Intervention code [1] 1816 0
Other interventions
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 2807 0
Effective weight loss after insertion of an adjustable Gastric Band is dependent on patient selection, surgical placement and close patient follow up, including intermittent band adjustments. Too little inflation can result in inadequate restriction and weight loss while too much inflation can result in too much restriction and an increased risk of oesophageal and gastric pouch complications. To date band adjustment are based on the volume of fluid used to inflate the band. The volume is usually assessed on patient feedback. The current approach is not objective.

The information gained from this study will be used to determine if it is feasible to use pressure based adjustments of the Swedish Adjustable Gastric Band. If it is successful an alternative objective method may be used to determine if a gastric band is adjusted appropriately.
Timepoint [1] 2807 0
The assessment will be made at the time of adjustment.
Secondary outcome [1] 4732 0
Determine which media and volume produces the optimal most consistent intra-band pressure patterns.
Timepoint [1] 4732 0
All assessments will be measured at the time of band adjustment. Only one adjustment will be made. Measurements wil include Maximum pressure, number of peak pressure readings, time to return to baseline. Incidence of adverse events.
Secondary outcome [2] 4733 0
Determine the variability of static and dynamic pressure measurments.
Timepoint [2] 4733 0
All assessments will be measured at the time of band adjustment. Only one adjustment will be made. Measurements wil include Maximum pressure, number of peak pressure readings, time to return to baseline. Incidence of adverse events.

Eligibility
Key inclusion criteria
Provide informed consent. Documented date of Gastric Band insertionUndergoing 1st, 2nd or 3rd band adjustment
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Females known to be pregnantKnown food allergies to the test mediaHistory of port obstructionCurrent port infectionHistory of revision of band systemHistory of oesophageal dysmotility or dilationConsumption of solid food within 4 hours of study band adjustmentConsumption of liquids within 2 hours of study band adjustmentAny condition that in the opinion of the investigator may jeopardize the subject's well-being and/or the soundness of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The investigator will not be permitted to view the computer screen showing the pressure readings during band adjustment. Only the trained study assistant will have access to the data at any given time.
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
592
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2126 0
Commercial sector/Industry
Name [1] 2126 0
Ethicon Endo-Surgery
Country [1] 2126 0
Primary sponsor type
Commercial sector/Industry
Name
Ethicon Endo-Surgery
Address
Country
Secondary sponsor category [1] 1933 0
Commercial sector/Industry
Name [1] 1933 0
Johnson and Johnson Medical
Address [1] 1933 0
Country [1] 1933 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 3921 0
Bellberry Human Research Ethics Committee-the Institute of Weight Control in Baulkham Hills
Ethics committee address [1] 3921 0
Ethics committee country [1] 3921 0
Australia
Date submitted for ethics approval [1] 3921 0
Approval date [1] 3921 0
Ethics approval number [1] 3921 0
Ethics committee name [2] 3922 0
Bellberry Human Research Ethics Committee-The Adelaide Bariatric Centre
Ethics committee address [2] 3922 0
Ethics committee country [2] 3922 0
Australia
Date submitted for ethics approval [2] 3922 0
Approval date [2] 3922 0
Ethics approval number [2] 3922 0

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

Contacts
Principal investigator
Name 27630 0
Address 27630 0
Country 27630 0
Phone 27630 0
Fax 27630 0
Email 27630 0
Contact person for public queries
Name 11005 0
Fiona Smith
Address 11005 0
Johnson and Johnson Medical
1-5 Khartoum Rd
North Ryde NSW 2113
Country 11005 0
Australia
Phone 11005 0
+61 2 98789000
Fax 11005 0
Email 11005 0
fsmith2@medau.jnj.com
Contact person for scientific queries
Name 1933 0
Fiona Smith
Address 1933 0
Johnson and Johnson Medical
1-5 Khartoum Rd
North Ryde NSW 2113
Country 1933 0
Australia
Phone 1933 0
+61 2 98789000
Fax 1933 0
Email 1933 0
fsmith2@medau.jnj.com

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.