Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. It is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
The EndoFLIP balloon catheter will be introduced to the band and used to permit the band stoma size to be adjusted to 7mm.
Specialty Surgery of Fort Worth
Hurst, Texas, United States
%Excess Weight Loss 4-6 Weeks After Surgery (Large and Small Bands)
Time frame: 4-6 weeks post surgery
%Excess Weight Loss 4-6 Weeks After Surgery (Small Bands Only)
Time frame: 4-6 weeks post surgery
% Excess Weight Loss 12 Months After Surgery (Large and Small Bands)
Time frame: 12m post surgery
% Excess Weight Loss 12 Months After Surgery (Small Bands Only)
Time frame: 12m post surgery
Number of Band Adjustments Required in the First Year After Surgery
Time frame: 12 months
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