Use of Adjustable Gastric Band in Adolescents

Not Applicable

Withdrawn

• Conditions: OBESITY
• Interventions: Device: REALIZE Gastric band (ETHICON)

• Registration Number: NCT01882049
• Lead Sponsor: University of Minnesota

Brief Summary

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

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2013-06-17
• Study First Posted: 2013-06-20
• Status Verified: 2016-05
• Study Start: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

BMI: Female: ≥ 27 - ≥ 33 Male ≥ 26 - ≥ 30.5

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	REALIZE Gastric band (ETHICON)	Use of Realize gastric band (Ethicon) in adolescents for weight reduction

Primary Outcome Measures

Name	Time	Method
Weight loss	Monthly up to one year	Reduction in percent of excess weight loss (%EWL).

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States