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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
Intraband pressure will be measured by a pressure recording system.
Band adjustments will be made via conventional standard of care (e.g., volume, hunger).
Adelaide Bariatric Center
Bedford Park, South Australia, Australia
OB Klinika, a.s.
Prague, Czechia
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.
Time frame: Screening to Day 180
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)
Time frame: Day 180
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).
Time frame: Screening to Day 180
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