CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 137 enrolled
Drug / intervention
Laparoscopic adjustable gastric banding (Allergan Lap Band)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01045499
NCT01045499N/ACompleted
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Laparoscopic Adjustable Gastric Banding (LAGB) as a Treatment for Morbid Obesity in Adolescents

Jeffrey L Zitsman, MD·interventional·Posted Jan 11, 2010·Updated Apr 13, 2020

In Brief

A clinical study evaluating Laparoscopic adjustable gastric banding (Allergan Lap Band) for Morbid Obesity and 4 related conditions. Completed, enrolled 137 participants across 1 site.

Detailed Summary

Laparoscopic adjustable gastric banding (LAGB) has been used worldwide to help selected morbidly obese adults to lose weight. The FDA has approved LAGB only for patients 18 years or older. Our hypothesis that LAGB can be used to assist selected adolescents between 14 and 17 years lose weight and that the procedure can be performed safely in this age group. We are also evaluating the effects of weight loss after LAGB on known comorbid conditions such as sleep apnea syndrome and insulin resistance, and also on psychological health.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMorbid Obesity, Obstructive Sleep Apnea Syndrome, Metabolic Syndrome, Insulin Resistance, Nonalcoholic Fatty Liver Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2010
Enrollment StartSep 13, 2005
Primary CompletionJul 31, 2016
Study CompletionApr 30, 2017
TodayJul 2, 2026
Enrollment to primary: 10.9 yearsPosted 16.5 years ago

Interventions

Laparoscopic adjustable gastric banding (Allergan Lap Band)device

Pre-op evaluation, surgical placement of a gastric band, and follow-up for a minimum of 5 years after surgery. Surgery is laparoscopic adjustable gastric band placement using a single brand of gastric band. Evaluations before and after surgery include but are not limited to history and physical examination, serum chemistry studies, imaging, sleep studies, and pulmonary function testing.