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OpenTrials
Completed

NCT Number: NCT01619488

Laparoscopic Adjustable Gastric Banding in Adolescents

This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

A I duPont Hospital for Children/Nemours Children's Clinic

Wilmington, Delaware, 19803, United States

About this study

This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ages 14-19
  • BMI > 35
  • history of obesity for at least 5 years with failed attempts at diet and medical management for at least 6 months.
  • confirmation by a pediatric psychologist that the subject is sufficiently mature emotionally and has adequate family support to comply with the study protocol.

Exclusion criteria

  • history of congenital or acquired anomalies of the GI tract.
  • history of esophageal motility disorders
  • uncontrolled psychiatric problems
  • previous esophageal, gastric or bariatric surgery; intestinal obstruction or peritonitis.
  • uncontrolled eating disorders

Treatment and study plan

Adjustable Gastric Band

Device

Surgical placement of an adjustable gastric band around the upper portion of the stomach.

Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.

Other names: Lap-Band

Primary outcomes

  1. Total Weight Loss

    Time frame: Up to five years post surgery.

    Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial

Secondary outcomes

  1. Insulin Resistance

    Time frame: Baseline

    Fasting insulin level

Sponsors and collaborators

Lead sponsor

Kirk Reichard

Other

Registry information

Official study title

Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Jun 14, 2012
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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