Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT00999661
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00999661
Study Brief:
Protocol Section:
NCT00999661