A Study of Clinical Outcomes of the REALIZE Adjustable Gastric Band-C
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Percent Excess Weight Change From Baseline to 24 Months [ Time Frame: 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.
Secondary Outcome Measures
% Excess Weight Change From Baseline to 12 Months [ Time Frame: 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.
Change in Body Mass Index From Baseline to 24 Months [ Time Frame: 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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
At each participating center (after the initial 10 cases), all consecutively implanted patients, will be considered for the study.
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.
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;
Anomalies of the gastrointestinal tract such as atresia or stenosis;
Cirrhosis of the liver;
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.