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NCT01619488 Clinical Trial

Laparoscopic Adjustable Gastric Banding in Adolescents

Morbid Obesity Clinical Trial

Official title:
Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01619488
Other study ID # 0082295
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 23, 2007
Est. completion date April 4, 2016

Study information
Verified date July 2023
Source Nemours Children's Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 57
Est. completion date April 4, 2016
Est. primary completion date April 4, 2016
Accepts healthy volunteers No
Gender All
Age group 14 Years to 19 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Adjustable Gastric Band
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.

Locations
Country Name City State
United States A I duPont Hospital for Children/Nemours Children's Clinic Wilmington Delaware

Sponsors (1)
Lead Sponsor Collaborator
Kirk Reichard

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total Weight Loss Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial Up to five years post surgery.
Secondary Insulin Resistance Fasting insulin level Baseline
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