Use of Adjustable Gastric Band in Adolescents

NCT ID: NCT01882049

Last Updated: 2016-05-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2016-05-31

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.

Conditions

OBESITY

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Use of Realize gastric band (Ethicon) in adolescents for weight reduction

Group Type: EXPERIMENTAL

REALIZE Gastric band (ETHICON)

Intervention Type: DEVICE

Placement of gastric band around upper stomach

Interventions

REALIZE Gastric band (ETHICON)

Placement of gastric band around upper stomach

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sayeed Ikrammudin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

IDE#G100290

Identifier Type: -

Identifier Source: org_study_id