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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

231 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Observational Model Type

COHORT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No