Use of Adjustable Gastric Band in Adolescents

OBESITY Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01882049
• Other study ID #: IDE#G100290
• Status: Withdrawn
• Phase: N/A
• First received: November 20, 2012
• Last updated: May 12, 2016
• Start date: May 2016
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• OBESITY

Intervention

Device:
• REALIZE Gastric band (ETHICON)
Placement of gastric band around upper stomach

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	Reduction in percent of excess weight loss (%EWL).	Monthly up to one year	No