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

Ethicon

Status: Completed

Conditions: Morbid Obesity

Study type: Observational

Funder types: Industry

Identifiers

NCT00999661

CI-09-0007

Details and patient eligibility

About

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.

Enrollment: 231 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.