An interventional study of REALIZE Gastric band (ETHICON) in OBESITY, sponsored by University of Minnesota. Withdrawn at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-05-16.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
This study is to investigate the use the adjustable gastric band for the treatment of obesity in adolescents.
Weight loss is related to the amount of energy or fuel obtained from the kinds and amounts of food eaten. When the amount of exercise and dieting uses less fuel than the amount taken in, the excess is stored as fat. The Adjustable Gastric Band used in this study is a tool to help the participant loose weight along with healthy eating, diet and exercise. This study involves minimally invasive laparoscopic surgery to place the adjustable band around the upper part of the stomach to make a smaller stomach or pouch about the size of a golf ball. One end of the band ends with a flat balloon that goes around the upper part of the stomach. The opening from this small stomach can be changed to allow more or less food into the intestine depending on the amount eaten and the amount of weight lost.
The other end of the of the band ends in a filling port through which saline solution is pumped with a needle through an attached tube to inflate or deflate the balloon. The filling port is attached to the wall of the abdomen under the skin. Because the flow of food is regulated by the band, most people feel full faster. This is how the appetite for food is controlled and the why the person is likely to eat less with the band in place.
Food is digested through the normal digestive process.
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BMI: Female: ≥ 27 - ≥ 33 Male ≥ 26 - ≥ 30.5
Exclusion Criteria:
•Hypertension: Systolic blood pressure (SBP) of 140 mm Hg
blood pressure
Use of Realize gastric band (Ethicon) in adolescents for weight reduction
Device: REALIZE Gastric band (ETHICON)
Placement of gastric band around upper stomach
Weight loss
Reduction in percent of excess weight loss (%EWL).
Time frame: Monthly up to one year
The record gives a start of May 2016, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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