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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00960843




Registration number
NCT00960843
Ethics application status
Date submitted
14/08/2009
Date registered
17/08/2009
Date last updated
14/08/2012

Titles & IDs
Public title
Six-month Study to Compare the Effects of Volume- and Pressure-Guided Adjustments on Weight Loss and Satiety
Scientific title
A Randomized, Controlled, 6-month Study to Compare the Effects of Volume- and Pressure-guided Adjustments on Weight Loss and Satiety in Patients Implanted With the Swedish Adjustable Gastric Band
Secondary ID [1] 0 0
CI-08-0009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Morbid Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Intraband pressure recording system
Other interventions - Conventional Adjustment

Active Comparator: Conventional Adjustment Group - Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).

Active Comparator: Intraband Pressure Arm - Subjects whose band adjustments will be guided by intraband pressure readings.


Treatment: Devices: Intraband pressure recording system
Intraband pressure will be measured by a pressure recording system.

Other interventions: Conventional Adjustment
Band adjustments will be made via conventional standard of care (e.g., volume, hunger).

Intervention code [1] 0 0
Treatment: Devices
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent Excess Weight Change at Day 180 - Percent Excess Weight Change will be calculated per subject as 100% times the difference between screening and Day 180 visit weight divided by the difference between screening weight and ideal body weight for a given sex and height of a subject. Excess weight is defined as the Screening Weight minus the ideal body weight. Ideal body weight is taken from the 1983 Metropolitan Life using the upper limit value of the medium frame range.
Timepoint [1] 0 0
Screening to Day 180
Secondary outcome [1] 0 0
Mean Static Intraband Pressure at Day 180 - Mean static Intraband Pressure will be automatically calculated by the Pressure Recording System as the sum of all pressure points divided by the number of seconds X 10 (10Hz data acquisition)
Timepoint [1] 0 0
Day 180
Secondary outcome [2] 0 0
Rate of Weight Loss kg/wk at Day 180 - Rate of weight loss = (screening weight (kg) - weight at Day 180 visit (kg)) / (number of days between screening and Day 180 visit / 7).
Timepoint [2] 0 0
Screening to Day 180

Eligibility
Key inclusion criteria
- Able to comprehend, follow and give informed consent.

- Be at least 18 years of age at time of trial enrollment.

- Had a pre-implantation BMI between 35 and 55 kg/m2.

- Have received a SAGB VC implant 1) 30-60 days (and not undergone first band adjustment
yet)prior to the date of enrollment.

- Willingness to be randomized to intraband-based or conventional adjustments

- Willingness to consent to monthly visits and possible measurements of intraband
pressure (requiring access to the injection port).

- Willingness to undergo up to 7 band adjustments within the 6-month period of the
study.

- Able to sit approximately at a 90 degree-angle, from the floor, for IBP measurements.

- Willingness to return to office visits around the same time of the first in-study
adjustment (plus or minus 2 hours)

- Willingness to consent to a limited UGI series if the investigator suspects the
presence of a band-related complication or if the intraband pressure recordings
deviate from expected.

- Willingness to refrain from taking medications or supplements indicated for or known
to induce weight loss.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Females currently known to be pregnant.

- Ongoing or unresolved band perforation or band leakage.

- Ongoing (unresolved) slippage, erosion, or pouch dilation.

- Documented esophageal dysmotility/dyskinesia.

- Ongoing (unresolved) port obstruction or tube kinking.

- Current injection port infection.

- History of band revision or replacement.

- Previously documented or ongoing esophageal dilatation.

- Any condition that, in the opinion of the Investigator, may jeopardize the subject's
well-being or the soundness of this study.

- Current use of medications or supplements indicated for or known to induce weight loss
at any point during the study.

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)
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
Parallel
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Adelaide Bariatric Center - Bedford Park
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
Czech Republic
State/province [1] 0 0
Prague

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Ethicon Endo-Surgery
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this protocol is to determine how band fill volumes that are based on
intraband pressure readings can influence the comfortability of the band and to compare
weight loss with this methodology to weight loss with the conventional approach recommended
in existing product labeling.
Trial website
https://clinicaltrials.gov/show/NCT00960843
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Summary results
Other publications