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

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

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.

Inclusion Criteria:

1. Received an implant with the Realize Band-C according to the following indications for use:

   1. 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.
   2. Male and female adult patients (adult is defined as 18 years of age or older)
   3. Failed more conservative weight-reduction alternatives, such as supervised diet, exercise, and behavior modification programs.

2. Able to comprehend, follow, and give signed informed consent.

Exclusion Criteria:

1. Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulceration or duodenal ulceration, or specific inflammation such as Crohn's disease;
2. Severe cardiopulmonary disease or other serious organic disease;
3. Upper gastrointestinal bleeding conditions such as esophageal or gastric varices or intestinal telangiectases;
4. Portal hypertension;
5. Anomalies of the gastrointestinal tract such as atresia or stenosis;
6. Cirrhosis of the liver;
7. Chronic pancreatitis;
8. Localized or systemic infection;
9. On chronic, long-term systemic steroid treatment or systemic steroids within 15 days of surgery;
10. Unable or unwilling to comply with dietary restrictions required by this procedure;
11. Known allergy to materials contained in the gastric band or its Injection Port;
12. Women who are pregnant;
13. Women at childbearing potential planning to get pregnant within 2 years or not using acceptable methods of contraception.