Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2

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

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