A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C
Completed
Conditions studied: Morbid Obesity
In brief
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.
Key facts
- Study ID
- NCT00999661
- Run by
- Ethicon Endo-Surgery
- People needed
- 231
- Starts
- 2009-11-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2014-02-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Los Angeles, California, United States
- Study site — Celebration, Florida, United States
- Study site — Joliet, Illinois, United States
- Study site — Holland, Michigan, United States
- Study site — Patchogue, New York, United States
- Study site — Charlotte, North Carolina, United States
- Study site — Houston, Texas, United States
Full record on ClinicalTrials.gov
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