Use of Adjustable Gastric Band in Adolescents

OBESITY Clinical Trial

Official title: Use of the REALIZE™ Adjustable Gastric Band (Model 2200-X) in Adolescents

Status Withdrawn

Clinical Trial Summary

This study is to investigate the use the adjustable gastric band for the treatment of obesity in adolescents.

Clinical Trial Description

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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• OBESITY

• NCT number: NCT01882049
• Study type: Interventional
• Source: University of Minnesota - Clinical and Translational Science Institute
• Status: Withdrawn
• Phase: N/A
• Start date: May 2016
• Completion date: May 2016