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 @ 5:06 PM
Ignite Modification Date:
2025-12-24 @ 5:06 PM
NCT ID:
NCT01929850
Eligibility Criteria:
Inclusion Criteria: Patients who are morbidly obese.
1. Female, age 18-65 years
2. Meeting the criteria as outlined in Part 2 A (Synopsis) of a medically underserved, rural, poor or underrepresented minority.
3. BMI \> 40 and \< 55, or BMI \> 35 and \<55 with one or more significant comorbidities. Co-morbidities are defined as diabetes, pulmonary disease, cardiac disease, or hypertension \[systolic blood pressure of ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg (or both) or on treatment for hypertension\]
4. History of obesity for at least 2.5 years
5. History of failure with non-surgical weight loss methods
6. Agree to comply with the substantial dietary restrictions and exercise program required by the procedure
7. Signed approval by physician and psychologist of subject's physical and mental suitability for bariatric surgery
8. Understands risks of procedures, agree to follow protocol requirements, including signing informed consent, returning for follow-up visits and completing all required testing, completing diet and behavior modification counseling.
9. Subject is a resident within the state of California or the city of Bangkok, Thailand and will likely remain so for a 2 year period of time.
10. Willingness to participate in weekly visits with Weight Watchers International local program.
Exclusion Criteria:
1. Subject history of inflammatory disease of the gastrointestinal tract including Crohn's disease or ulcerative colitis
2. Significant known esophageal disease including grade 3-4 esophagitis, active gastric ulcer disease or active duodenal ulcer disease
3. Severe coagulopathy, upper GI bleeding conditions such as esophageal or gastric varices, congenital or acquired telangiectasia
4. Congenital or acquired anomalies of the GI tract such as atresias or stenoses.
5. Severe cardiopulmonary disease or other serious organic disease including HIV or cancer
6. Currently pregnant or nursing. Potentially childbearing (i.e. not post-menopausal or surgically sterilized) and not willing to use an effective method of contraception for the next 12 months
7. Current alcohol or drug addiction
8. Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator or psychologist/psychiatrist, make the subject a poor candidate for this procedure
9. Previous gastric, esophageal, pancreatic, or bariatric surgery
10. Infection anywhere in the body at the time of the procedure
11. Subject history of scleroderma, amyloidosis
12. Thyroid disease which is not controlled with medication
13. Hormonal or genetic cause for the obese state.
14. History of cancer other than localized basal cell carcinoma.
15. Myocardial infarction or cerebrovascular accident within past year.
16. Angina pectoris.
17. Severe coagulopathy (prothrombin time \> 3 seconds over control or platelet count \< 100,000)
18. Gastroparesis or pyloric stenosis.
19. Lesions with increased risk of bleeding.
20. Severe cardiopulmonary disease or other serious organic disease, including HIV or cancer.
21. Congestive heart failure.
22. Uncontrolled hypertension (systolic \> 150 or diastolic \> 100).
23. Severe or advanced liver disease (such as cirrhosis, chronic hepatitis, portal hypertension, etc.).
24. Severe reflux disease.
25. Active, continuous alcohol consumption (\> 80 gm/day of ethanol) or chronic illicit drug use within the last 3 years.
26. Currently on prescription or over the counter diet drugs.
27. Chronic therapy with aspirin, NSAID or anticoagulants.
28. Not ambulatory.
29. Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.
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Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01929850
Study Brief:
Protocol Section:
NCT01929850