Six-month Study to Compare the Effects of Volume- and Pressure-Guided Adjustments on Weight Loss and Satiety
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|ClinicalTrials.gov Identifier: NCT00960843|
Recruitment Status : Completed
First Posted : August 18, 2009
Results First Posted : April 3, 2012
Last Update Posted : August 20, 2012
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Device: Intraband pressure recording system Other: Conventional Adjustment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
Active Comparator: Conventional Adjustment Group
Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
Other: Conventional Adjustment
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.
Device: Intraband pressure recording system
Intraband pressure will be measured by a pressure recording system.
- Percent Excess Weight Change at Day 180 [ Time Frame: Screening to 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.
- Mean Static Intraband Pressure at Day 180 [ Time Frame: 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)
- Rate of Weight Loss kg/wk at Day 180 [ Time Frame: Screening to 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00960843
|Australia, South Australia|
|Adelaide Bariatric Center|
|Bedford Park, South Australia, Australia, 5042|
|OB Klinika, a.s.|
|Prague, Czech Republic|