Status:
COMPLETED
A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Morbid Obesity
Eligibility:
All Genders
18+ years
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT00999661
Start Date
November 1 2009
End Date
May 1 2012
Last Update
February 7 2014
Active Locations (7)
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1
Los Angeles, California, United States
2
Celebration, Florida, United States
3
Joliet, Illinois, United States
4
Holland, Michigan, United States