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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

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