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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT01718457
Eligibility Criteria:
Inclusion Criteria:
1. Subjects willing to comply with study requirements and have signed an informed consent form.
2. Age 18-65
3. BMI ≥ 30 kg/m²
4. HbA1c% as assessed by central laboratory ≥ 8.0%.
5. Documented negative pregnancy test in women of childbearing potential.
6. Women of childbearing potential agree to remain on contraceptives for the duration of their trial participation.
Exclusion Criteria:
1. Subjects taking systemic corticosteroids or drugs known to affect GI motility within 30 days prior to randomization
2. Subjects receiving any prescription or over the counter weight loss medication within 30 days prior to randomization (including GLP-1 analogs).
3. Previous GI surgery that could preclude the ability to place the EndoBarrier device, liner or affect the function of the implant
4. Subjects with a history of abnormal GI anatomical findings documented on imaging study, which in the opinion of the Investigator, may impair implantation of the EndoBarrier device
5. Subjects with active GERD not taking a Proton Pump Inhibitor (PPI)
6. Subjects with symptomatic kidney stones within 6 months prior to randomization.
7. Known abnormal pathologies or conditions of the gastrointestinal tract, including ulcers or Crohn's disease, atresias or stenoses, upper gastro-intestinal bleeding conditions
8. Subjects with symptomatic gallstones within 6 months prior to randomization
9. Coagulopathy defined as hgb \<10g/dl and platelet \< 100,000/ml or diagnosis of hemophilia, factor X deficiencies or fibrinogen abnormalities
10. Any documented history of acute or chronic pancreatitis
11. Subjects requiring prescription antithrombotic therapy (i.e. anticoagulant or antiplatelet agent)
12. Subjects unable to discontinue Aspirin or any other NSAIDs (non-steroidal anti-inflammatory drugs) or any other drugs with bleeding as a potential side effect (i.e coumadin) during the study duration
13. Known diagnosis of systemic lupus erythematosus, scleroderma or other autoimmune connective tissue disorder
14. Subject is or has been enrolled in another investigational study within 3 months of participation into the EndoBarrier study
15. Subjects with poor dentition who cannot completely chew their food.
16. Subjects with thyroid disease unless controlled with a therapeutic dose of medication and have normal thyroid function tests for a minimum of 6 months prior to randomization
17. Subjects not residing within a 3 hour driving distance of the study center.
18. Subjects with an abnormal laboratory or ECG abnormality which the investigators deems clinically significant and makes the patient a poor candidate for the study
19. Subjects with known allergies or hypersensitivity to ceftrixone, cephalosporins or penicillin
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01718457
Study Brief:
Protocol Section:
NCT01718457