Use of Adjustable Gastric Band in Adolescents

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

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

Study Overview

• Status: Withdrawn
• Conditions: OBESITY
• Intervention / Treatment: Device: REALIZE Gastric band (ETHICON)

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Sayeed Ikrammudin, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (Estimate): June 20, 2013

Study Record Updates

• Last Update Posted (Estimate): May 16, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: IDE#G100290