Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2
Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2
This study is to evaluate the safety and efficacy of Gastric Banding for patients with body
 mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.
TITLE OF STUDY:A prospective study to evaluate the safety and efficacy of LAP-BAND®
 Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with
 co-morbidities

 CLINICAL PHASE: Phase III new indication for use of the device not yet approved by FDA

 STUDY OBJECTIVES

 -  To determine the safety and efficacy of the LAP-BAND® Adjustable Gastric Band (LAGB®)
 for patients with BMI between 30-40 kg/m2 with co-morbidities

 -  To determine long-term effects on patients' co-morbidities

 STUDY VARIABLES: Morbidity & mortality, percent of excess weight loss, nutritional status,
 improvement of pre-operative co-morbidities, weight loss maintained, and quality of life
 evaluation

 DESIGN: Prospective single center study
Inclusion Criteria:

 -  Be at least 18 and equal to or less than 60 years of age.

 -  BMI of at least 30 and maximum BMI of 40 with co-morbidities

 -  Willingness to comply with dietary restrictions required by the protocol

 -  History of obesity for at least 5 years

 -  History of at least 6 months of documented failures with traditional non-surgical
 weight loss methods

 -  Willingness to follow protocol requirements

 -  If female with childbearing potential, using an appropriate form of contraception

 Exclusion Criteria:

 -  Age less than 18, age greater than 60

 -  Pregnancy

 -  History of major depressive disorder or psychosis

 -  Previous bariatric surgery or previous gastric surgery

 -  Presence of achalasia

 -  Presence of portal hypertension, cirrhosis, and/or varices

 -  Patient with inflammatory disease of the gastrointestinal tract such as Crohn's
 Disease

 -  Patients with autoimmune connective tissue disorders

 -  Patients with acute abdominal infections

 -  Any condition that, in the judgment of the investigator, would place a subject at
 undue risk, or potentially compromise the results or interpretation of the study