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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Device: LAP-BAND® Adjustable Gastric Band (LAGB®)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAGB for low BMI patients<br>the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities | Device: LAP-BAND® Adjustable Gastric Band (LAGB®)<br>* Bariatric surgery for patient whose BMI is between 30 and 40 kg/m^2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery | Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery | Change in level of LDL from baseline at 5 years | 5 years | 
| Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery | Change in level of Triglycerides from baseline at 5 years | 5 years | 
| Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery | Change in level of HbA1c from baseline at 5 years | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, 50 lbs overweight