Use of Adjustable Gastric Band in Adolescents

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

Detailed Description
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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.

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

Conditions
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OBESITY

Intervention / Treatment
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* Device: REALIZE Gastric band (ETHICON)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI: Female: ≥ 27 - ≥ 33 Male ≥ 26 - ≥ 30.5 Exclusion Criteria: •Hypertension: Systolic blood pressure (SBP) of 140 mm Hg Hyperlipidemia: hyperlipidemia depends on Obstructive Sleep Apnea: Metabolic Syndrom: The presence of any three of the following: abdominal obesity - dimensons for children? triglycerides -cholesterol - fasting glucose blood pressure overweight Non-surgical means of weight reduction failure of Significant psychopathology (absence of ) that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations, as documented during screening assessment; Agrees to refrain from any type of reconstructive surgery that would affect body weight such as abdominal lipoplasty or liposuction, mammoplasty, or removal of excess skin for three years following SAGB placement; and Candidate for surgical weight loss intervention (i.e., meets accepted health criteria for major surgery.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Use of Realize gastric band (Ethicon) in adolescents for weight reduction | Device: REALIZE Gastric band (ETHICON)<br>* Placement of gastric band around upper stomach<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | Reduction in percent of excess weight loss (%EWL). | Monthly up to one year |