Overview

This trial is active, not recruiting.

Condition morbid obesity
Treatment adjustable gastric band
Phase phase 3
Sponsor Kirk Reichard
Start date August 2007
End date May 2018
Trial size 75 participants
Trial identifier NCT01619488, 0082295

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
adjustable gastric band Lap-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.

Primary Outcomes

Measure
weight loss
time frame: every 6 months for 5 years

Secondary Outcomes

Measure
The secondary objective is to assess the status of co-morbidities and changes in quality of life scores that occur in adolescents after surgical weight loss.
time frame: followed for 5 years

Eligibility Criteria

Male or female participants from 14 years up to 17 years old.

Inclusion Criteria: - ages 14-17 - BMI > 40 - 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

Additional Information

Official title Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents
Principal investigator Kirk Reichard, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Nemours Children's Clinic.