Laparoscopic Adjustable Gastric Banding in Adolescents
This trial is active, not recruiting.
|Treatment||adjustable gastric band|
|Start date||August 2007|
|End date||May 2018|
|Trial size||75 participants|
|Trial identifier||NCT01619488, 0082295|
This study is to determine if the Lap-band system is safe and effective for use in morbidly obese adolescents.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
time frame: every 6 months for 5 years
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
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
|Official title||Laparoscopic Adjustable Gastric Banding for Treatment of Morbid Obesity in Adolescents|
|Principal investigator||Kirk Reichard, MD|
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