Safety and Efficacy of Adjustable Gastric Band Operations for Patients With Body Mass Index (BMI) Between 30-40 kg/m2
- Conditions
- Obesity
- Interventions
- Device: LAP-BAND® Adjustable Gastric Band (LAGB®)
- Registration Number
- NCT00580502
- Lead Sponsor
- NYU Langone Health
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LAGB for low BMI patients LAP-BAND® Adjustable Gastric Band (LAGB®) the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities
- Primary Outcome Measures
Name Time Method To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery 5 years Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.
- Secondary Outcome Measures
Name Time Method Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery 5 years Change in level of LDL from baseline at 5 years
Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery 5 years Change in level of Triglycerides from baseline at 5 years
Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery 5 years Change in level of HbA1c from baseline at 5 years