A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the results patients are obtaining with the Realize™ Adjustable Gastric Band-C during the first 24 months after surgery.

Official Title
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A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C at 2 Years in a US Patient Population of Morbidly Obese Patients

Conditions
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Morbid Obesity

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received an implant with the Realize Band-C according to the following indications for use: Body Mass Index (BMI) of at least 40 kg/m2, or a BMI of at least 35 kg/m2 with one or more co-morbid conditions. Male and female adult patients (adult is defined as 18 years of age or older) Failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs. Able to comprehend, follow, and give signed informed consent. Exclusion Criteria: Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease; Severe cardiopulmonary disease or other serious organic disease; Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases; Portal hypertension; Anomalies of the gastrointestinal tract such as atresia or stenosis; Cirrhosis of the liver; Chronic pancreatitis; Localized or systemic infection; On chronic, long-term systemic steroid treatment or systemic steroids within 15 days of surgery; Unable or unwilling to comply with dietary restrictions required by this procedure; Known allergy to materials contained in the gastric band or its Injection Port; Women who are pregnant; Women at childbearing potential planning to get pregnant within 2 years or not using acceptable methods of contraception.

Ages Eligible for Study
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Minimum Age: 18 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Excess Weight Change From Baseline to 24 Months | Percent excess weight change from baseline to 24 months was calculated as (the baseline weight minus the weight at 24 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects. | Baseline to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Excess Weight Change From Baseline to 12 Months | Percent excess weight change from baseline to 12 months was calculated as (the baseline weight minus the weight at 12 months) divided by the (baseline weight minus the ideal body weight (using the upper limit of the midpoint range in the Metropolitan Tables for Life Insurance, 1983) x 100). Last observation carried forward was used for early terminated subjects. | Baseline to 12 months | 
| Change in Body Mass Index From Baseline to 24 Months | Change in Body Mass Index from Baseline to 24 months with last observation carried forward. The calculation was performed as the Body Mass Index at 24 months minus the Body Mass Index at Baseline. | Baseline to 24 months |